MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. ALL-POLY PATELLA CEMENTED 29 MM DI; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Malposition of Device (2616); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930)
Date of Event	08/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: australia.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was requested but not returned by the facility.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted additional associated products: 42522100810  articular surface medial congruent (mc) right 10 mm  lot# 64726737.
Event or Problem Description
It was reported the patient was revised three years post implantation due to implant wear and malposition of the patella.Patella was wearing laterally and tracking poorly.Articular surface was replaced due to possible infection as a precaution.
Additional Manufacturer Narrative
this follow-up report is being submitted to relay additional information.  no product was returned and the pictures provided were insufficient to complete visual and dimensional evaluations.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Insufficient information provided.Unable to perform a compatibility check.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: significant radiolucency on the patella, overall fit and alignment of the patellar component is appropriate, and normal bone quality.The complaint is not confirmed.A definitive root cause cannot be determined for the patella wear.The implanted products are not identified as the source or contributing to the reported infection, as there are no indications of a product or process issues identified affecting implant safety or effectiveness no corrective actions, preventive actions, or field actions resulted after investigation of this event.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: ALL-POLY PATELLA CEMENTED 29 MM DI
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• 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: 17604657
• Report Number: 0002648920-2023-00201
• Device Sequence Number: 6283712
• Product Code: JWH
• UDI-Device Identifier: 00889024247680
• UDI-Public: (01)00889024247680(17)241031(10)64545068
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K172524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 42540200029
• Device Lot Number: 64545068
• 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: 08/01/2023
• Supplement Date Received by Manufacturer: 12/12/2023
• Initial Report FDA Received Date: 08/23/2023
• Supplement Report FDA Received Date: 12/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2019
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 85 KG