MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD UNI TIB BRG LG SZ4; KNEE PROSTHESIS

Catalog Number	154635
Medical Device Problem Codes	Fracture (1260); Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately twenty years after initial implantation, the patient underwent a revision surgery due to bearing fracture.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 tibial component; item# unknown; lot# unknown.Unknown femoral component; item# unknown; lot# unknown.G2 - foreign: united kingdom.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Additional Manufacturer Narrative
Cmp-0916968 this follow-up report is being submitted to relay additional information.The following sections were updated: a1, a2, a3, a4, b4, b5, b7, d4, d9, d10, g3, g6, h2, h4, h6, h11.D10 - associated medical devices: oxford uni tib tray 53x34 rllm; item# 154615; lot# 683522; oxford uni femoral lg; item# 154602; lot# 639948.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 approximately twenty years after an initial left partial knee replacement, the patient was revised due to poly insert fracture at the medial posterior corner.During the revision, the surgeon also noted moderate wear of the poly.Poly was exchanged without complications.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.Assessment was conducted on the returned oxford bearing, which was in-vivo for approximately 20 years.The item was examined under magnification.While the bearing is fractured, no other fragments of the bearing were returned for examination.Both the superior and inferior surface of the bearing show evidence of multiple scratches, gouges, and/or abrasions.Additionally, the inferior surface shows some material missing from the medial posterior corner.There is also a significant indentation on the inferior side in the area of the missing material, with possible evidence of delamination or cracking.The anterior side of the bearing displays a worn area, which includes signs of possible creep or cold flow of uhmwpe material.Operative notes from the revision were provided and reviewed by a health care professional.The review identified the following: general anesthesia, previous incision utilized.Eua full rom, small effusion, no signs of infection.Poly insert medial posterior corner missing, small fragments retrieved, moderate wear.New poly stable, full rom.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.Based on the available information, a definitive root cause could not be determined.However, examination of the returned product indicates that the damage in the bearing surface was likely caused by overloading.This may have been influenced by a misalignment or movement of the bearing within the joint space, resulting in loading and articulation being shifted posteriorly.Further, the damage could have been exacerbated by embrittlement due to potential long-term oxidation of the uhmwpe.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 UNI TIB BRG LG SZ4
• 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: 18648488
• Report Number: 3002806535-2024-00039
• Device Sequence Number: 8192456
• Product Code: NRA
• UDI-Device Identifier: 05019279388400
• UDI-Public: (01)05019279388400(17)090228(10)741663
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P010014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• 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,Followup
• Report Date (Section B): 07/04/2024

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: 02/28/2009
• Device Catalogue Number: 154635
• Device Lot Number: 741663
• 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: 01/08/2024
• Supplement Date Received by Manufacturer: 05/21/2024; 06/27/2024
• Initial Report FDA Received Date: 02/06/2024
• Supplement Report FDA Received Date: 06/17/2024; 07/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2004
• 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.; SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 105 KG