MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. FEMUR CEMENTED POSTERIOR STABILIZED (PS) STANDARD RIGHT SIZE 11; PROSTHESIS, KNEE

Model Number	42-5006-070-02
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Ambulation or Postural Difficulties (2544)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: medical product: tibia cemented 5 degree stemmed right size g: catalog#42532007902, lot#63452411; palacos r 1x40 single: catalog#00111214001, lot#80434395; palacos r 1x40 single: catalog#00111214001, lot#83264476; all poly patella cemented 35 mm diameter: catalog#42540000035, lot#63538176; articular surface fixed bearing posterior stabilized (ps) right 10 mm height: catalog#42522401010, lot#63389413.Multiple mdr reports have been filed for this event.Please see associated reports: 3007963827-2023-00173; 0001822565-2023-01662; 0001822565-2023-01663.The product will not be returned to zimmer biomet for evaluation as the product remains implanted.The investigation is in progress.Upon completion of the investigation, a follow-up mdr will be submitted.H3 other text : see h10 narrative.
Event or Problem Description
It was reported that a patient underwent an initial right total knee arthroplasty.Subsequently, six (6) years post-implantation, the patient reported that they are being considered for a revision surgery due to pain and loosening.The patient has ambulation difficulties and must primarily wear a knee brace.A revision surgery is not currently scheduled and it was reported that no further information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.H6: proposed component (annex g) code is mechanical (g04) - femur.Visual and dimensional evaluations of the product could not be performed as no product was returned nor were pictures provided.Device history record was reviewed and no discrepancies related to the reported event were found.Primary operative notes were provided and do not indicate any intraoperative complications.Root cause was unable to be determined.This complaint cannot be confirmed.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 further event information at time of this report.

• Brand Name: FEMUR CEMENTED POSTERIOR STABILIZED (PS) STANDARD RIGHT SIZE 11
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• 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: 17167279
• Report Number: 3007963827-2023-00172
• Device Sequence Number: 5744649
• Product Code: JWH
• UDI-Device Identifier: 00889024229303
• UDI-Public: (01)00889024229303(17)260531(10)63367134
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K113369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2023

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 Expiration Date: 05/31/2026
• Device Model Number: 42-5006-070-02
• Device Catalogue Number: 42500607002
• Device Lot Number: 63367134
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2023
• Supplement Date Received by Manufacturer: 10/03/2023
• Initial Report FDA Received Date: 06/20/2023
• Supplement Report FDA Received Date: 10/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2016
• 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: Other
• Patient Sex: Male