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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a left knee arthroplasty revision of the articular surface to address pain approximately seven (7) years post-operatively.Attempts have been made, however, no additional information is available.
Additional Manufacturer Narrative
(b)(4).D10 - concomitant devices - nexgen prolong cr-flex articular surface c-h 12mm catalog #: 00595203012 lot #: ni, unknown nexgen femoral component catalog #: ni lot #: ni, unknown nexgen tibial tray catalog #: ni lot #: ni.G2 - report source - foreign: event occurred in australia.The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this patient; please see all reports associated with this event: 0001822565-2023-03760, 0001822565-2023-03762, 0001822565-2023-03763.H3 other text : investigation incomplete.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The reported event could not be confirmed due to lack of information provided; no devices were returned or medical records provided.There was a photo provided of the articular surface that showed evidence of use.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause could not be determined.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 additional information to report.

• Brand Name: NEXGEN ALL POLY PATELLA STANDARD CEMENTED SIZE 29MM
• 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: 18375115
• Report Number: 0002648920-2023-00318
• Device Sequence Number: 7712990
• Product Code: JWH
• UDI-Device Identifier: 00889024635371
• UDI-Public: (01)00889024635371(17)260630(10)64080690
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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
• Report Date (Section B): 04/04/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2026
• Device Model Number: N/A
• Device Catalogue Number: 00597206529
• Device Lot Number: 64080690
• 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: 11/30/2023
• Supplement Date Received by Manufacturer: 04/03/2024
• Initial Report FDA Received Date: 12/21/2023
• Supplement Report FDA Received Date: 04/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female