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

Model Number	N/A
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/28/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).This is combined initial and final mdr.D10: item# 154927; lot# 1695918; oxford ph3 cementless fem sz l.Item# 166577; lot# 1446606; oxf uni cmntls tib sz d rm.G2- australia.Visual examination of the provided pictures identified evidence of heavy wear and discolouration on the spherical bearing face with half of the bearing missing.A review of the device manufacturing records could not be performed due to missing lot number.Review of the complaint history identified additional similar complaints for the reported item.However, due to the lack of the lot number, an additional lot search could not be performed.Medical records were provided and reviewed by a hcp.The review identified that revision hemiarthroplasty of the right knee was required due to wear of the bearing component.No operative record provided for revision.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
It was reported that the patient underwent revision surgery due to poly wear.The poly was exchanged.Approximately 14 years and 3 months post-implantation.Attempts have been made and all additional information received has been included in this report.

• Brand Name: OXF ANAT BRG RT LG 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: 19825206
• Report Number: 3002806535-2024-00271
• Device Sequence Number: 8891434
• Product Code: NRA
• UDI-Device Identifier: 05019279786282
• UDI-Public: (01)05019279786282
• 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: 2010
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/25/2024

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 Model Number: N/A
• Device Catalogue Number: 159582
• Device Lot Number: UNKNOWN
• 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: 07/02/2024
• Initial Report FDA Received Date: 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Required Intervention; Hospitalization
• Patient Sex: Male