MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. FEMUR CEMENTED (PS) STANDARD RIGHT SIZE 8; PROSTHESIS, KNEE

Catalog Number	42500606402
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Swelling/ Edema (4577); Joint effusion (4849); Aseptic loosening (4883); Tendinopathy (4887)
Date of Event	11/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient was revised approximately four years two and a half months post implantation due to aseptic loosening.During the revision the patella was found to be grossly loose, the femoral and tibial components were found to be slightly mobile and aseptic loosening was confirmed.Attempts to obtain additional information have been made; however, no more information is available.
Additional Manufacturer Narrative
(b)(4).D10-medical product all-poly patella cemented 35 mm diameter item# 42540200035, lot# 64435171.Tibia cemented 5 degree stemmed right size f item# 42532007502, lot# 64177602.Palacos cement x2 item# 5036964, lot# 88814741.Stem extension tapered cemented 14 mm diameter +30 mm length item# 42557000114, lot# 64412165.Articular surface fixed bearing (ps) right 10 mm height item# 42522400710, lot# 64281993.H3- customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.H6: component code: proposed component (annex g) code is: - mechanical (g04) - femur.
Additional Manufacturer Narrative
This report is being submitted to provide additional information.Updated: b4, b5, d2, g1, g3, g6, h1, h2, h3, h6, h10, and h11.No product was returned, or pictures provided; therefore, visual and dimensional evaluations could not be performed.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: the patient initially progressed well after mua with good range of motion, but then began experiencing recurrent right knee pain, swelling, and effusions, sometimes following minor activities such as walking up stairs.Multiple aspirations were performed, with no clear evidence of infection though fluid was collected.Imaging over time (x-rays, mri, bone scan) showed persistent pain, quadriceps tendinitis, patellar tendinopathy with focal tear, and ultimately findings suspicious for prosthesis loosening.Eventually loosening of the right knee prosthesis was confirmed, with low suspicion of infection despite transiently elevated labs.The patient expressed a preference not to use zimmer implants.A revision surgery was performed: intraoperative findings confirmed aseptic loosening of the patellar, femoral, and tibial components, with significant scar tissue removed.New smith & nephew implants were placed, achieving excellent stability, range of motion, and patellar tracking, and the patient was discharged in stable condition.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.This complaint is confirmed based on the provided medical records.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: FEMUR CEMENTED (PS) STANDARD RIGHT SIZE 8
• 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: 22286282
• Report Number: 3007963827-2025-00243
• Device Sequence Number: 12876334
• Product Code: JWH
• UDI-Device Identifier: 00889024229242
• UDI-Public: (01)00889024229242(17)280531(10)64046879
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K113369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2025

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: 42500606402
• Device Lot Number: 64046879
• 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: 05/22/2025
• Supplement Date Received by Manufacturer: 10/15/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 10/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/25/2018
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 108 KG