MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD ANAT BRG RT MD SIZE 5 PMA; KNEE PROSTHESIS

Catalog Number	159577
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Dislocation (2374)
Date of Event	04/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately a year after the initial implantation, the patient underwent a revision due to bearing dislocation while performing everyday activities.The surgeon noted that the bearing showed signs of material consumption and worn out edges.The remaining implants show no signs of loosening.Due diligence is in progress for this complaint; no further additional information or product has been received.
Additional Manufacturer Narrative
(b)(4) d10 - associated medical devices: oxford uni twin-peg femoral md; item# 166942; lot# j7469838 oxf uni tib tray sz d rm pma; item# 154725; lot# 7290114 g2 - foreign: poland investigation of this incident is currently ongoing.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.Visual examination of the returned product identified signs of use (nicked, gouged) and confirmed that implant exhibits wear.Dimensional analysis of the product determined that the product, where measured, was conforming to the print specifications, however, due to wear, the thickness could not be measured.A review of the device manufacturing records confirmed no abnormalities or deviations.Review of the complaint histories identified additional similar complaints for the reported item and no additional similar complaints for the reported part and lot combination.Complaints are monitored per complaint trending process.Radiographs were provided and reviewed.There are multiple undated images therefore a timeline could not be established to correlate to the allegation of dislocation and/or wear.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 5 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: 19402950
• Report Number: 3002806535-2024-00189
• Device Sequence Number: 15190048
• Product Code: NRA
• UDI-Device Identifier: 05019279786237
• UDI-Public: (01)05019279786237(17)280112(10)7420825
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: P010014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 10/14/2024

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 Catalogue Number: 159577
• Device Lot Number: 7420825
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 04/29/2024
• Supplement Date Received by Manufacturer: 10/04/2024
• Initial Report FDA Received Date: 05/28/2024
• Supplement Report FDA Received Date: 10/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2023
• 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: Unknown