MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ALL POLY PAT COMP PRLG 32 DIA; PROSTHESIS, KNEE

Catalog Number	00597206632
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the legal team that the patient underwent a right knee revision approximately 7 years post implantation due to unknown reasons.It was reported that no further information is available.
Additional Manufacturer Narrative
(b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Additional Manufacturer Narrative
Upon receiving additional information of the reported event, it was determined to be not reportable as there are no allegations against this device.The initial report should be voided.
Event or Problem Description
Upon receiving additional information of the reported event, it was determined to be not reportable as there are no allegations against this device.The initial report should be voided.

• Brand Name: ALL POLY PAT COMP PRLG 32 DIA
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 21950884
• Report Number: 0001822565-2025-01238
• Device Sequence Number: 18343025
• Product Code: JWH
• UDI-Device Identifier: 00889024215207
• UDI-Public: (01)00889024215207(17)210831(10)63432275
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K072281
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: 00597206632
• Device Lot Number: 63432275
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2025
• Supplement Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 05/02/2025
• Supplement Report FDA Received Date: 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/25/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 99 KG