MAUDE Adverse Event Report: BIOMET UK LTD. UNKNOWN OXFORD BEARING; OXFORD PARTIAL KNEE SYSTEM

Model Number N/A

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

Patient Problem Insufficient Information (4580)

Event Date 03/03/2021

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.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent an initial left knee arthroplasty on an unknown date in 2008.Subsequently, a revision procedure due to implant fracture was performed on (b)(6) 2021.

Event Description

It was reported that a patient underwent an initial left knee arthroplasty on (b)(6) 2008.Subsequently, a revision procedure due to a fractured oxford bearing was performed on (b)(6) 2021.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information and correct the product name.We were informed by the sales representative that the reported product was a femoral component.We have since identified that this information was incorrect.We confirm that the reported event was a revision due to a fracture of an unknown oxford bearing.The following sections were updated: b4, b5, d1, d2, d4, g3, h1, h2, h3, h6, h10.As the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.In addition, we have not been provided with x-rays or any supporting documentation which could provide additional information.A review of the manufacturing history records confirms no abnormalities or deviations reported.Mhr review could not be performed as item number and lot number is unknown.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.

Manufacturer Narrative

(b)(4).This supplemental report is being submitted to relay additional information and correct the location where the event occurred.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent an initial left knee arthroplasty on (b)(6) 2008.Subsequently, a revision procedure due to implant fracture was performed on (b)(6) 2021.

• Brand Name: UNKNOWN OXFORD BEARING
• Type of Device: OXFORD PARTIAL KNEE SYSTEM
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 11573864
• MDR Text Key: 242392233
• Report Number: 3002806535-2021-00088
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• PMA/PMN Number: P010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2021
• 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: UNK OXFORD BEARING
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Weight: 113