MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. STEM EXTENSION; 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	10/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported patient underwent a revision procedure two years post implantation due to pain.Attempts to obtain additional information have been made; however, no more is available.
Additional Manufacturer Narrative
(b)(4).D10 - medical product: cruciate retaining cr-flex gender solutions female (gsf) femoral component porous catalog # 00575201701 lot # 64226041.Articular surface catalog # 00595204012 lot # 64590070.All poly petella catalog # 00597206535 lot # 64620687.Stemmed tibial component catalog # 00598004702 lot # j6960308.Headed screw 48 mm length catalog # 00579104100 lot # 65003879.Headed screw 48 mm length catalog # 00579104100 lot # 65011599.Headless screw 48 mm length catalog # 00579104200 lot # 65011608.Headless screw 48 mm length catalog # 00579104200 lot # 65082493.Headless screw 48 mm length catalog # 00579104200 lot # 65082498.Headless screw 48 mm length catalog # 00579104200 lot # 65143820.Headed screw 27 mm length catalog # 00579104300 lot # 64744149.Headed screw 27 mm length catalog # 00579104300 lot # 64744149.H6: suggested component code: mechanical (g04) - stem.G2: australia.Multiple mdr reports were filled for this event: 0001822565-2024-00596.0001822565-2024-00597.0002648920-2024-00044.0001822565-2024-00598.Reported event was unable to be confirmed due to limited information received from the customer.Device was not returned.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot 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.

• Brand Name: STEM EXTENSION
• 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: 18737729
• Report Number: 0002648920-2024-00045
• Device Sequence Number: 20566459
• Product Code: JWH
• UDI-Device Identifier: 00889024221147
• UDI-Public: (01)00889024221147(17)310217(10)64894141
• 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: 2021
• Device Explanted Year: 2023
• 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
• Report Date (Section B): 02/20/2024

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 Model Number: N/A
• Device Catalogue Number: 00598801215
• Device Lot Number: 64894141
• 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: 10/19/2023
• Initial Report FDA Received Date: 02/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2021
• 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: Required Intervention; Hospitalization
• Patient Sex: Prefer Not To Disclose