MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA POSTERIOR STABILIZED CEMENTED FEMUR; KNEE PROSTHESIS

Model Number N/A

Device Problems Material Discolored (1170); Packaging Problem (3007)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/29/2016

Event Type  malfunction  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

Upon opening the product, there was a film and discoloration of the plastic packaging and on the implant itself.Another device was used to complete the surgery.

Manufacturer Narrative

This report will be amended when our investigation is complete.Returned, not yet evaluated.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.Not all the packaging elements were returned.As received the packaging box exhibits damage as well as the ldpe bag item (b)(4), which appears cloudy.The femoral component features a small faint discoloration on the inside of the antero-medial shield.The device history records for the catalog #42-5006-066-02, lot # 62330555 were reviewed and no deviations or anomalies were identified.The product was considered to have left zimmer biomet conforming as there is no requirements for bag clarity, and there was no biocompatibility or product damage issue.This device is used for treatment.A compliant history search identified no other complaint for the part/lot combination and no complaint from the same issue for the part number alone.The surface of the bag is micro-abraded and becomes cloudy when rubbed due to the presence of an anti-block agent used to prevent the bag from sticking to itself and to the product.This cloudy bag issue does not constitute a biocompatibility or a product damage issue.Therefore, the root cause is considered to be a cosmetic issue.

• Brand Name: PERSONA POSTERIOR STABILIZED CEMENTED FEMUR
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; east park, shannon indust pk.; building 2; shannon, county clare V14 W N80; EI V14 WN80
• Manufacturer (Section G): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare V14 W N80; EI V14 WN80
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582-0708 ; 5745273773
• MDR Report Key: 5822712
• MDR Text Key: 50453952
• Report Number: 3007963827-2016-00054
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PK113369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 42500606602
• Device Lot Number: 62330555
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/30/2016
• Initial Date FDA Received: 07/26/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 09/01/2016; 01/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1