MAUDE Adverse Event Report: BIOMET UK LTD. OXF TRL BRG W/SLOTS MED 3MM; BMET GENERAL KNEE INSTRUMENTS

Model Number N/A

Device Problem Fracture (1260)

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

Event Date 05/09/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).Investigation of this incident is currently ongoing.A followup/ final report will be submitted when additional information becomes available.

Event Description

It was reported that during initial right knee arthroplasty, when the surgeon took out the spacer from the knee, it broke.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.Investigation has been completed.The following sections were updated: b4, b5, d9, g3, g6, h1, h2, h3, h6, h10.The product was not returned for investigation.Therefore, visual and dimensional evaluation could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing.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 TRL BRG W/SLOTS MED 3MM
• Type of Device: BMET GENERAL KNEE INSTRUMENTS
• 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: 14601516
• MDR Text Key: 293351735
• Report Number: 3002806535-2022-00267
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279346813
• UDI-Public: (01)05019279346813(11)160120(10)ZB150201
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 32-422703
• Device Lot Number: ZB150201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1