MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD TWIN-PEG CMNTD FEM SM PMA; KNEE PROSTHESIS

Catalog Number	161468
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that ten years and six most post partial knee arthroplasty, the patient had to undergo a revision due to pain.During the procedure, it was noted that there was some wear to the bearing.Due diligence is in progress for this complaint; to date no additional information has been received.
Additional Manufacturer Narrative
(b)(4).D10 - associated medical devices: oxf anat brg rt sm size 3 pma; item# 159568; lot# 2682445 oxf uni tib tray sz b rm pma; item# 154721; lot# unknown.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2024-00110 3002806535-2024-00111.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, a2, a4, b4, b5, b7, d4, g3, g6, h2, h4, h11.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.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: b4, b5, d9, g3, g6, h1, h2, h3, h6, h11.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2024-00110, 3002806535-2024-00111.Visual examination of the returned products identified signs of use (nicked, gouged) and confirming complaint has significant wear.Due to wear no measurements taken.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.Review of the complaint histories identified additional similar complaints for the reported items and no additional similar complaints for the reported part and lot combinations.Radiographs were provided and reviewed by a radiologist.The review identified two views right knee dated over four (4) years after implantation demonstrates a medial compartment hemiarthroplasty with radiolucency along the cement hardware interface of the tibial component.Joint space narrowing could indicate polyethylene wear.Two views right knee dated about six (6) years after implantation demonstrates medial compartment hemiarthroplasty with persistent findings of polyethylene wear and possible loosening of the tibial component.Two views right knee dated eleven (11) years after implantation demonstrates medial compartment hemiarthroplasty with persistent findings of polyethylene wear and possible loosening of the tibial component.Medial compartment hemiarthroplasty of the right knee with possible polyethylene wear and loosening of the tibial component.Sizing is appropriate.Mild osteopenia.There is possible polyethylene wear and loosening of the tibial component.Possible polyethylene wear and loosening of the tibial component.Both of these findings can cause pain.With given 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.

• Brand Name: OXFORD TWIN-PEG CMNTD FEM SM 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: 18969556
• Report Number: 3002806535-2024-00112
• Device Sequence Number: 12315403
• Product Code: NRA
• UDI-Device Identifier: 05019279438228
• UDI-Public: (01)05019279438228(17)230228(10)2957769
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P010014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/26/2024

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: 161468
• Device Lot Number: 2957769
• Was Device Available for Evaluation?: Yes
• 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: 02/29/2024
• Supplement Date Received by Manufacturer: 03/27/2024; 07/17/2024
• Initial Report FDA Received Date: 03/25/2024
• Supplement Report FDA Received Date: 04/22/2024; 07/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2013
• 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: Hospitalization; Required Intervention
• Patient Sex: Prefer Not To Disclose
• Patient Weight: 70 KG