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

Model Number N/A

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

Patient Problem Insufficient Information (4580)

Event Date 07/27/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device not returned.

Event Description

T was reported that a patient underwent an initial knee arthroplasty on (b)(6) 2021 subsequently, a revision procedure due to wound closure issues was performed on (b)(6) 2021.

Event Description

It was reported that a patient underwent an initial knee arthroplasty on (b)(6) 2021 subsequently, a revision procedure due to unknown reason was performed on (b)(6) ,2021.

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: 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.A review of the complaint database over the last 3 years has found 2 complaints reported with the item 159575(including initiating complaint).Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.Capa: no corrective or preventive action required at this time.The investigation is completed based on current available information.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 knee arthroplasty on (b)(6) 2021.Subsequently, a revision procedure due to unknown reason was performed on (b)(6) 2021.

Manufacturer Narrative

(b)(4).This final follow-up report is being submitted to relay additional information.Additional information received: complaint database review update: 4 complaints reported with the item 159575 (including initiating complaint).Complaint summary: 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.A review of the complaint database over the last 3 years has found 4 complaints reported with the item 159575 (including initiating complaint).Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

• Brand Name: OXF ANAT BRG RT 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
• MDR Report Key: 12272717
• MDR Text Key: 264950482
• Report Number: 3002806535-2021-00340
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279786213
• UDI-Public: 05019279786213
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 09/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2021
• 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: 159575
• Device Lot Number: 915870
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/24/2021
• 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