MAUDE Adverse Event Report: BIOMET UK LTD. OXF TWIN-PEG CMNTD FEM LG PMA; KNEE PROSTHESIS

Model Number N/A

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

Patient Problem Insufficient Information (4580)

Event Date 05/25/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10- oxf uni tib tray sz d rm pma, item #(b)(4), lot# 999960.Oxf anat brg rt lg size 3 pma item#(b)(4), lot#385560.Biomet bone cement r 1x40 us item# (b)(4), lot# 745aah1407.Multiple mdr reports were filed for this event, see associated reports: 3002806535-2023-00197; 3002806535-2023-00200.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that the patient underwent an initial partial knee arthroplasty and approximately 5 years later a revision surgery was performed due to unknown reason.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Event Description

Upon reassessment of the reported event, it was determined to be a duplicate of mfr report number 3002806535-2023-00193.Hence this report should be voided.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined to be a duplicate of mfr report number 3002806535-2023-00193.Hence this report should be voided.

• Brand Name: OXF TWIN-PEG CMNTD FEM LG PMA
• Type of Device: KNEE PROSTHESIS
• 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: 17253689
• MDR Text Key: 318350506
• Report Number: 3002806535-2023-00198
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279438259
• UDI-Public: (01)05019279438259(17)281013(10)016890
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 161470
• Device Lot Number: 016890
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2018
• 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
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male