MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. TIBIA CEMENTED 5 DEGREE STEMMED RIGHT SIZE F; PROSTHESIS, KNEE

Catalog Number	42532007502
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930); Insufficient Information (4580)
Date of Event	01/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient was revised approximately six and a half years post implantation due to loosening and possible infection.Attempts to obtain additional information have been made; however, no more information is available at this time.
Additional Manufacturer Narrative
(b)(4).D10-medical product: femur cemented (cr) standard right size 9 item# 42502606602, lot# 63938496.G2- australia.H3- customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.Updated: b4, d2, g1, g3, g6, h1, h2, and h11.Corrected: b5, h6.
Event or Problem Description
It was reported that a patient was revised approximately six and a half years post implantation due to instability.Attempts to obtain additional information have been made; however, no more information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Tibia loosening is confirmed based on review of provided x-ray.However, the revision was reported to be due to instability which was not confirmed.Device history record 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 report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No additional information reported.

• Brand Name: TIBIA CEMENTED 5 DEGREE STEMMED RIGHT SIZE F
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare
• Manufacturer (Section G): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 21457584
• Report Number: 3007963827-2025-00073
• Device Sequence Number: 7591430
• Product Code: JWH
• UDI-Device Identifier: 00889024471085
• UDI-Public: (01)00889024471085(17)271031(10)63821005
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K122765
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2025
• 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): 05/13/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 42532007502
• Device Lot Number: 63821005
• 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: 01/30/2025
• Supplement Date Received by Manufacturer: 03/02/2025; 05/07/2025
• Initial Report FDA Received Date: 02/25/2025
• Supplement Report FDA Received Date: 03/26/2025; 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2017
• 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 Age: 75 YR
• Patient Sex: Unknown