MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG LT MD SIZE 3 PMA; OXFORD HXLPE BEARINGS

Model Number N/A

Device Problems Break (1069); Fracture (1260); Material Integrity Problem (2978)

Patient Problem Insufficient Information (4580)

Event Date 12/01/2021

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.No associated products.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device has been retained by the surgeon.

Event Description

It was reported that a patient underwent an initial left knee arthroplasty on (b)(6) 2003.Subsequently, a revision procedure for the fractured oxford bearing due to wear was performed, on (b)(6) 2021.Patient involvement - revision.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.Complaint summary: the event did not occur during surgery.Device revision or replacement the device is used for treatment.The reported event could not be confirmed as the product was not returned for review and information was insufficient to make a definitive confirmation.Visual inspection of the returned part could not be conducted as the product was not returned.The dimensional check was not carried out as the product was not returned for review.No assembly checks were carried out as the product was not returned for review.The material review was not conducted as the lot number stated on the per was not confirmed to correspond to the part number.Three attempts were made to request confirmation without success.Dhr review was not conducted as the lot number stated on the per was not confirmed to correspond to the part number.Three attempts were made to request confirmation without success.The product item no.159547 lot: s587066 has not been involved in any previous capas or field actions.No corrective actions are required at this time.Medical records and x-rays were requested but not provided.The risk assessment and occurrence rate could not be completed as an item number could not be confirmed.The root cause could not be defined with the available information if any additional information becomes available, then the complaint will be reopened and investigated further.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.

Event Description

It was reported, that: a patient underwent an initial left knee arthroplasty on (b)(6), 2003.Subsequently, a revision procedure due to fractured oxford bearing due to wear was performed on (b)(6), 2021.Patient involvement - revision.

• Brand Name: OXF ANAT BRG LT MD SIZE 3 PMA
• Type of Device: OXFORD HXLPE BEARINGS
• 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: 12959364
• MDR Text Key: 281902218
• Report Number: 3002806535-2021-00519
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279785933
• UDI-Public: 05019279785933
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2021
• 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: 159547
• Device Lot Number: S587066
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/04/2022
• 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
• Patient Outcome(s): Required Intervention; Hospitalization