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

Catalog Number 161468

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

Patient Problem Insufficient Information (4580)

Event Date 01/29/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10 - associated medical devices: oxf uni tib tray sz b rm pma; item# 154721; lot# 592820.Oxf anat brg rt sm size 3 pma; item# 159568; lot# 218830.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2024-00071.3002806535-2024-00073.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 a revision surgery approximately seven years post initial implantation due to unknown reasons.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2024-00071-1.3002806535-2024-00073-1.This follow-up report is being submitted to relay additional and/or corrected information.No products were returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.With the available information, a definitive root cause could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

• Brand Name: OXF TWIN-PEG CMNTD FEM SM 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: 18776189
• MDR Text Key: 336183072
• Report Number: 3002806535-2024-00072
• Device Sequence Number: 1
• Product Code: NRA
• 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: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 161468
• Device Lot Number: 332200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Prefer Not To Disclose