MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG LT LG SIZE 6 PMA; UNICONDYLAR KNEE PROSTHESIS

Model Number N/A

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

Patient Problem No Information (3190)

Event Date 09/15/2020

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.

Event Description

It was reported that a patient underwent an initial left knee arthroplasty on (b)(6) 2020.Subsequently, a revision procedure due to unknown reason was performed on (b)(6) 2020.

Event Description

It was reported that a patient underwent an initial left knee arthroplasty on (b)(6) 2020.Subsequently, a revision procedure due to unknown reason was performed on (b)(6) 2020.Additional information received: it was reported that a patient underwent an initial left knee arthroplasty on (b)(6) 2020.Subsequently, a revision procedure due to wound was performed on (b)(6) 2020.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.Additional information received: subject: revision due to wound.Initial and revision procedures performed at the same hospital and by same surgeon.Investigation completed.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.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 and 1 scrap piece was found.A review of the complaint database over the last 3 years has found no similar complaints reported with item and lot combination.A review of the complaint database over the last 3 years has found 1 similar complaints reported with the item 159557.No trends were identified with respect to similar complaints.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.Risk assessment: the event reports revision due to wound.A risk assessment cannot be carried out at this time, as a reason for the wound has not been reported.Information received stated that the wound was not infected.If further information regarding the root cause of the reported event is provided, risk should be re-assessed.No corrective or preventive actions are deemed necessary at this time.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.

• Brand Name: OXF ANAT BRG LT LG SIZE 6 PMA
• Type of Device: UNICONDYLAR KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 10634595
• MDR Text Key: 209974804
• Report Number: 3002806535-2020-00442
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279786039
• UDI-Public: 05019279786039
• 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
• Report Date: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/25/2023
• Device Model Number: N/A
• Device Catalogue Number: 159557
• Device Lot Number: 569040
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/14/2020
• 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