MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD ANAT BRG RT MD SIZE 4 PMA; KNEE PROSTHESIS

Catalog Number	159576
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient initially underwent a right knee arthroplasty.Approximately four years post-implantation, the patient twisted their knee while working on their car and experienced persistent soreness thereafter.Approximately eight years and ten months post-implantation, the patient underwent a revision surgery to replace the bearing, which was found to be misoriented.During the revision surgery, the bearing was found to be intact, with only minor damages attributed to edge loading and the positional change that occurred following the reported knee injury.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
(b)(4).D10 - associated medical devices: unknown oxford femoral component; item# unknown; lot# unknown.Unknown oxford tibial component; item# unknown; lot# unknown.G2 - foreign: australia.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: a1, a3, b4, b5, d10, e1, g3, g6, h2, h11.D10 - associated medical devices: oxford ph3 cementless fem sz m; item# 154926; lot# 3775260 oxf uni cmntls tib sz e rm; item# 166579; lot# 3331553 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 is available at the time of this report.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, g3, g6, h2, h3, h6, h11.The product involved in the reported event was not returned for investigation; however, pictures were provided.The review identified some damaged (scratches) to the bearing.A review of the device manufacturing records confirmed no abnormalities or deviations.Review of the complaint history found no additional related complaints for this item and the reported part and lot combination.Radiographs were provided and reviewed.The review identified that the bearing orientation is not correct in relation to the femoral and tibial components.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 report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: OXFORD ANAT BRG RT MD SIZE 4 PMA
• Common Device Name: KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22554119
• Report Number: 3002806535-2025-00275
• Device Sequence Number: 21278231
• Product Code: NRA
• UDI-Device Identifier: 05019279786220
• UDI-Public: (01)05019279786220(17)210630(10)3827175
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P010014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 10/24/2025

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: Lay User/Patient
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: 159576
• Device Lot Number: 3827175
• 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: 06/25/2025
• Supplement Date Received by Manufacturer: 07/22/2025; 10/06/2025
• Initial Report FDA Received Date: 07/21/2025
• Supplement Report FDA Received Date: 08/19/2025; 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2016
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male