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

Catalog Number 32-422703

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/21/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during the surgery, when trial was made, the oxford art surface broke into the patient body.All pieces were found.There were no pieces remaining in the patient body.All pieces were found and removed.The trial was finished, they did not have to open an other instrument.There was no consequence on the patient health/life.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.The trail bearing exhibits signs of use.The instrument was in the field for approximately 3 years and 3 months.The foot of the trial bearing has fractured.The most likely root cause is mispositioning of the tibial bearing inserter.When the inserter is not engaged with the bearing properly, the forces are not distributed across the trial bearing, but rather applied on the thin foot of the bearing.This together with wear and tear is the most likely cause of the fracture.However, the exact root cause cannot be established.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported that during the surgery, when trial was made, the oxford art surface broke into the patient body.All pieces were found and removed.The trial was finished, they did not have to open another instrument.There was no consequence on the patient health/life.

• Brand Name: OXF TRL BRG W/SLOTS MED 3MM MM
• Type of Device: BMET GENERAL KNEE INSTRUMENTS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 7998943
• MDR Text Key: 125131941
• Report Number: 3002806535-2018-01150
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• PMA/PMN Number: P010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 08/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 32-422703
• Device Lot Number: ZB150601
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention