M05.01.01.01 Rev . 30
PRODUCT EXPERIENCE REPORT
Effective Date : June 13 , 2022
B . PRODUCT INFORMATION : One form should be used per event and / or patient . If more than , one device is associated with a single event being reported , multiple Item numbers may be included below . Additional rows may be added , or additional information included as necessary . NOTE : 1 ) Please make sure product listed below has been properly decontaminated . 2 ) For non-Patient Specific Products , return only the complaint product . 3 ) For ZFX products please indicate Order number if possible : ______________
Item Number *
( If available , affix patient record label )
Lot / Serial Number *
Qty .*
Replacement Requested
Is Product Being Returned ?*
Yes No
If No , Why ?* ( i . e . retained by the hospital , scrapped , etc .)
Discarded |
Used |
Remains Implanted |
Other : |
Is destructive analysis permitted ?*
Discarded |
Used |
Remains Implanted |
Other : |
C . REPORTER INFORMATION Reporter Name *
Date of Report * |
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Is the person submitting this report |
Clinician |
Lab |
Distributor |
Sales Representative |
Account Name Account #* Address City , State , Zip , Country Contact Name * Phone #* E-mail *
D . PATIENT INFORMATION Patient Identifier * Gender * |
Male |
Female |
Age at the time of the event * Weight |
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Instructions for returning complaint product :
1 . ( US , Canada , APAC and non-European Reporters ) Complete the Product Experience Report ( PER ) editable PDF , save and email to the appropriate ZimVie complaint handling contact email ( see page 3 ). The complaint handling contact will reply with the complaint number ( CMP #( s )) and the product return instruction .
2 . ( All other reporters ) Complete the Product Experience Report ( PER ) editable PDF , save and print . The printed form will be shipped along with the sterile product to the appropriate complaint handling site ( see page 3 ).
3 . If a Serious Adverse Event related to Human Tissue occurs in the UK , the reporter has an obligation to notify Biomet3i UK , Ltd within 24 hours of event ’ s discovery . Complaint Contact details are located on page 3 of this form . 4 . Contaminated product shall be sterilized and identified as STERILE . 5 . Return product labeled with the CMP # ( if known ) in an appropriate shipping container along with a copy of this completed PER form to the addresses provided and / or indicated on page 3 of this form .
Note : This information is being gathered to assist in complying with regulatory requirements in the USA and other countries as applicable . Completion of this form does not constitute an admission that medical personnel , distributor , manufacturer , or product caused or contributed to the event .
Template D01.02.00.03 Rev 2 , Eff . Date : March 02,2022 Ref .
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