MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD UNI CMNTLS TIB SZ C LM; OXFORD CEMENTLESS TIBIAL TRAYS

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Insufficient Information (4580)

Event Date 02/06/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10 - medical devices.Oxford ph3 cementless fem sz m; item# 154926; lot# 7074536.Unknown bearing; item# unknown; lot# unknown.G2 - foreign: australia.Multiple mdr reports were filed for this event, please see associated reports: 3002806535 - 2024 - 00058.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 a patient had a cementless initial left unicompartmental knee replacement performed.Subsequently, the patient was revised due to unspecified symptoms, vague hot spots identified on ct, and potential infection.During the revision, the tibial component was replaced with a cemented tibia, and the bearing was also exchanged.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and corrected information.The product has been discarded and was not available for investigation.Visual examination of the provided pictures identified only little evidence of bony ongrowth on the tibial tray which was implanted for approximately eighteen months before revision surgery.The bearing does not appear to be damaged or worn, however based on the quality of the provided photograph a conclusive assessment cannot be determined.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.Medical records were provided and reviewed by a health care professional.The review identified that the information provided is insufficient and inconclusive regarding symptoms, allegations, and findings upon revision.Infection is suspected but not confirmed and cannot be correlated with vague hot spots found on ct.Recommend serious injury at this time due to insufficient information as symptoms necessitated revision surgery in which the initial device cannot be ruled out.The hot spots found on ct scans could represent infection or loosening.The visual examination identified only little evidence of bony ongrowth on the tibial tray which could possibly point to loosening.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.

Event Description

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

• Brand Name: OXFORD UNI CMNTLS TIB SZ C LM
• Type of Device: OXFORD CEMENTLESS TIBIAL TRAYS
• 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: 18710549
• MDR Text Key: 335464321
• Report Number: 3002806535-2024-00057
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P010014/S078
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/28/2024

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
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 166574
• Device Lot Number: 7126610
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/06/2024
• Initial Date FDA Received: 02/15/2024
• Supplement Dates Manufacturer Received: 03/18/2024
• Supplement Dates FDA Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female