MAUDE Adverse Event Report: BIOMET UK LTD. OXF DOMED LAT MEN BRNG SZ 3 UK; KNEE ARTHROPLASTY

Model Number N/A

Device Problem Unstable (1667)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/07/2021

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

Event Description

It was reported that a patient underwent an initial knee arthroplasty on an (b)(6) 2021.Subsequently, the patient fell and had to have a revision procedure due to instability was performed on (b)(6) 2021.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.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 (b)(4) complaint reported with the item 161687 including initiating complaint.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.

Event Description

It was reported that a patient underwent an initial knee arthroplasty on (b)(6) 2021.Subsequently, the patient fell and had to have a revision procedure due to instability was performed on (b)(6) 2021.

• Brand Name: OXF DOMED LAT MEN BRNG SZ 3 UK
• Type of Device: KNEE ARTHROPLASTY
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 11875214
• MDR Text Key: 252350754
• Report Number: 3002806535-2021-00223
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279103836
• UDI-Public: (01)05019279103836(17)220704(10)6092495
• Combination Product (y/n): N
• PMA/PMN Number: P01004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/04/2022
• Device Model Number: N/A
• Device Catalogue Number: 161687
• Device Lot Number: 6092495
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/03/2021
• 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