MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN MEDIUM 22.5MM THICKNESS CEMENTED AUGMENTATION PATELLA; PROSTHESIS, KNEE

Catalog Number	00587601022
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Necrosis (1971); Pain (1994)
Date of Event	02/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient underwent an initial total knee arthroplasty on an unknown date.Subsequently, on an unknown timeframe post-implantation, the patient underwent revision surgery due to avascular necrosis fracture of the patella.Due diligence is in progress for this event; to date no further information has been reported.
Additional Manufacturer Narrative
(b)(4).D10: medical product: unknown femoral component: catalog#ni, lot#ni; unknown tibial tray: catalog#ni, lot#ni; unknown articular surface: catalog#ni, lot#ni g2: foreign: australia the product will not be returned to zimmer biomet for investigation, as the product location is unknown.The investigation is in process.Upon receipt of additional information or completion of the investigation, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that patient underwent an initial total knee arthroplasty on an unknown date.On an unknown timeframe post-implantation, the patient began to experience pain and subsequently underwent revision surgery due to avascular necrosis fracture of the patella.Due diligence is complete as multiple attempts have been made; all available information has been reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The investigation is in process.Upon completion of the investigation, a follow-up mdr will be submitted.
Event or Problem Description
Upon receipt of additional information, it was determined that the previously reported device was implanted at the patient revision surgery.The explanted device that led to the patient complications was a competitor product and not manufactured by zimmer biomet.The previous initial and supplemental reports were forwarded in error.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Upon receipt of additional information, it was determined that the previously reported device was implanted at the patient revision surgery.The explanted device that led to the patient complications was a competitor product and not manufactured by zimmer biomet.The previous initial and supplemental reports were forwarded in error.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: NEXGEN MEDIUM 22.5MM THICKNESS CEMENTED AUGMENTATION PATELLA
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18934209
• Report Number: 0001822565-2024-00935
• Device Sequence Number: 11907029
• Product Code: JWH
• UDI-Device Identifier: 00889024309654
• UDI-Public: (01)00889024309654(17)280508(10)65846726
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K004013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/26/2024

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 Catalogue Number: 00587601022
• Device Lot Number: 65846726
• 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: 02/21/2024
• Supplement Date Received by Manufacturer: 03/20/2024; 06/28/2024
• Initial Report FDA Received Date: 03/19/2024
• Supplement Report FDA Received Date: 04/12/2024; 07/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Prefer Not To Disclose