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

Catalog Number 159547

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 11/14/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that approximately nine years and eight months after initial implantation, the patient underwent a revision due to knee bearing implant fracture.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Event Description

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

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified that the bearing was fractured into two pieces with both being returned for evaluation.Only the lot number of the returned product could be confirmed to match the complaint as the item number was not engraved on the part.Product was not returned in its original packaging.The item was implanted for approximately 10 years.The superior surface presents linear wear marks along with minor pitting or gouging which is typical with in vitro use.Also, the medial side of the bearing has possible delamination from the anterior to posterior sides of the implant.The inferior side has an asymmetrical pattern of wear or abrasions, mostly anterior to the fracture.The anterior medial of the inferior side also has no apparent wear or abrasion markings.A hole has been drilled through the anterior side through to the articulating surface; this was presumably associated with explantation.The anterior side also has evidence of possible delamination.The fracture surfaces of both halves of the part both show evidence of subsurface white banding, which is a typical sign of oxidation in uhmwpe.A review of the device manufacturing records confirmed no abnormalities or deviations.Medical records were provided and reviewed by a health care professional.The review identified that the bearing was found in place but broken in half and the patient developed pain and left knee varus deformity.The anterior and posterior parts were in appropriate position however, the patient was bearing metal-on metal.The lateral compartment was intact and the implants were found to be stable.The x-ray showed complete disruption of the polyethylene bearing.After a new bearing was implanted, the knee was taken through rom and tracked well with the alignment assessed to be "back to normal".No intraoperative complications were reported.Based on the visual examination a possible root cause could be due to the bearing surface becoming misaligned with the tibial component causing uneven wear and abrasions on the inferior side, and the inferior side.The loading on the bearing possibly became shifted to the medial side of the bearing, resulting in overloading and possible delamination with high oxidation.However, 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.

• Brand Name: OXF ANAT BRG LT 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: 18282177
• MDR Text Key: 329935952
• Report Number: 3002806535-2023-00414
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/06/2019
• Device Catalogue Number: 159547
• Device Lot Number: 785510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2014
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 116 KG
• Patient Race: White