MAUDE Adverse Event Report: BIOMET UK LTD. OXF UNI TIB TRAY SZ AA RM PMA; OXFORD CEMENTED TIBIAL TRAYS

Model Number N/A

Device Problems Naturally Worn (2988); Patient Device Interaction Problem (4001)

Patient Problem Pain (1994)

Event Date 08/24/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report.Report source, foreign - event occurred in (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it has been discarded.Associated products: medical product: oxford uni twin-peg femoral xs.Catalog no.: 166940.Lot no.: j6084869.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00399.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that: uka was performed with oxford on (b)(6) 2018.Postoperatively, the patient who underwent the initial operation felt a pain to see a doctor.At the diagnosis, tibial tray sinking was confirmed.A revision was performed to replace the tibial tray, bearing and femoral component on (b)(6) 2021.At the revision, the surgeon confirmed wear on the explanted bearing.Patient involved.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h1, h2, h3, h6, h10.Complaint summary: the product has not been returned for evaluation.Therefore, the investigation has been limited to the information provided, a review of the x-rays and device history records.The manufacturing history records (mhrs) of the tibial tray, meniscal bearing and associated femoral component have been checked and verify that the parts were manufactured and sterilised in accordance with the applicable specifications.Review of complaint history identified no additional similar complaints for the reported items and no additional complaints for the reported item 159532 and lot 6108810 combination and item160791 and lot 6240110 combination.These devices are used for treatment.The reported event is related to a combination of products which are compatible.These part and lot combinations are not associated with any recalls at the time the search was conducted.Based on the available information, it appears that the reported patient¿s bone degeneration, possible sub-optimal component alignment and possible sub-optimal cementing technique may have contributed to the observed tibial tray sinking and to the reported wear on the explanted bearing, although the latter cannot be confirmed without examination of the revised part.Other contributing factors cannot be discussed without examination of the revised components, and without provision of additional radiographic, patient and surgical information.The likely condition of the devices when they left zimmer biomet is conforming to specification.The reported event has not been confirmed as the products have not been returned for evaluation and the dhr review did not identify any issues.The root cause of the reported event cannot be determined with the information provided.Corrective or preventative action not required.The root cause of the reported event cannot be determined with the information provided.The investigation is completed based on current available information.If any additional information becomes available, then the complaint will be reopened and further investigated.Multiple mdr reports were filed for this event, please see associated report: 3002806535-2021-00399-1.If any further information is found which would change or alter any conclusions or information, a supplemental will be submitted accordingly.Zimmer biomet will continue to monitor for trends.H3 other text : device discarded.

Event Description

It was reported that: uka was performed with oxford on (b)(6) 2018.Postoperatively, the patient who underwent the initial operation felt a pain to see a doctor.At the diagnosis, tibial tray sinking was confirmed.A revision was performed to replace the tibial tray, bearing and femoral component on (b)(6) 2021.At the revision, the surgeon confirmed wear on the explanted bearing.Patient involved.

• Brand Name: OXF UNI TIB TRAY SZ AA RM PMA
• Type of Device: OXFORD CEMENTED 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: 12524563
• MDR Text Key: 273089715
• Report Number: 3002806535-2021-00398
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279783144
• UDI-Public: 05019279783144
• 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,Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 159532
• Device Lot Number: 6108110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: SEEH10
• Patient Outcome(s): Hospitalization; Required Intervention