MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD ANAT BRG RT MD SIZE 3 PMA; KNEE PROSTHESIS

Catalog Number	159575
Medical Device Problem Codes	Fracture (1260); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Dislocation (2374)
Date of Event	03/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 associated medical devices: oxf uni tib tray sz c rm pma; item# 154723; lot# 3819016 oxford uni twin-peg femoral md; item# 166942; lot# j3670783 g2 - foreign: japan 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.
Event or Problem Description
It was reported that post an initial uka surgery, the patient experienced a bearing dislocation due to the the fracture of said bearing which resulted in revision surgery.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h2, h3, h6, h11.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.Radiographs were provided and reviewed by a radiologist.The review identified : a medial unicompartmental arthroplasty has been performed.There is no evidence of implant loosening.The radiopaque markers of the bearing are noted superolaterally consistent with dislocation of the bearing, likely into the lateral suprapatellar recess.There is narrowing of the medial implant tibiofemoral space and early lateral compartment arthrosis.Implant fit and alignment are overall maintained despite the bearing dislocation.Bone quality is osteopenic.The bearing dislocation is confirmed on the radiograph, but a bearing fracture cannot be confirmed on this image.Other than the bearing dislocation, no abnormality is identified.With the available information, 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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: OXFORD ANAT BRG RT MD SIZE 3 PMA
• Common Device Name: KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 19058278
• Report Number: 3002806535-2024-00128
• Device Sequence Number: 6753003
• Product Code: NRA
• UDI-Device Identifier: 05019279786213
• UDI-Public: (01)05019279786213(17)210520(10)3794388
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P010014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2024
• 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
• Report Date (Section B): 05/17/2024

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/20/2021
• Device Catalogue Number: 159575
• Device Lot Number: 3794388
• 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: 03/11/2024
• Supplement Date Received by Manufacturer: 05/02/2024
• Initial Report FDA Received Date: 04/08/2024
• Supplement Report FDA Received Date: 05/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2016
• 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 H11 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Prefer Not To Disclose