MAUDE Adverse Event Report: BIOMET UK LTD. OXF UNI TIB TRAY SZ D RM 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  

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.

Manufacturer Narrative

(b)(4).D10- oxf twin-peg cmntd fem lg pma, item161470, lot# 016890.Oxf anat brg rt lg size 3 pma item#159582, lot#385560.Biomet bone cement r 1x40 us item# 110035368, lot# 745aah1407.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2023-00197, 3002806535-2023-00198.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

Upon reassessment of the reported event, it was determined to be a duplicate of mfr report number 3002806535-2023-00194.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 3002806535-2023-00194.Hence this report should be voided.

• Brand Name: OXF UNI TIB TRAY SZ D RM 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: 17246875
• MDR Text Key: 318300205
• Report Number: 3002806535-2023-00200
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279388912
• UDI-Public: (01)05019279388912(17)280628(10)999960
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 154725
• Device Lot Number: 999960
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/05/2023
• Initial Date FDA Received: 07/03/2023
• Supplement Dates Manufacturer Received: 07/26/2023
• Supplement Dates FDA Received: 08/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2018
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male