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

Catalog Number 159575

Device Problems Fracture (1260); Device Dislodged or Dislocated (2923)

Patient Problems Failure of Implant (1924); Joint Dislocation (2374)

Event Date 03/07/2024

Event Type  Injury  

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 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.

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 Description

No further event information available at the time of this report.

• Brand Name: OXFORD ANAT BRG RT MD SIZE 3 PMA
• Type of Device: 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
• MDR Text Key: 339559726
• Report Number: 3002806535-2024-00128
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279786213
• UDI-Public: (01)05019279786213(17)210520(10)3794388
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/20/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H11 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Prefer Not To Disclose