MAUDE Adverse Event Report: BIOMET UK LTD. OXF TRIAL BEARING MED SZ 4/5; KNEE PROSTHESIS

Model Number N/A

Device Problem Break (1069)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Date 09/23/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has indicated that the product is in the process of being returned to zimmer biomet for investigation.Once the investigation is complete, a supplemental mdr will be submitted.The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.

Event Description

It was reported that during surgery the trial bearing handle broke off.The surgeon removed the femur in order to remove the 5mm bearing trial.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.It was reported that the surgeon was attempting to insert the final 5mm trial bearing when the handle broke off.The surgeon completed his final trialling and then had to remove the femur in order to remove the 5mm bearing trial.Product inspection confirmed that the handle has separated from the 5mm trial bearing.The product has been in the field for approximately 12 years and 3 months.The returned item shows that the handle was threaded into a fractured thread adaptor.The thread adaptor has come out of the blue pomalux bearing leaving behind the remainder of the thread adaptor.The trial bearing exhibits signs of damage.Multiple scratches can be seen on the inferior and superior surfaces in the longitudinal direction, which coincide with the implant articulation.The drawing of the 5mm trial bearing, attachment 1, indicates that there is no thread adaptor utilized as part of the design.The design of the trial bearing calls for the thread, to receive the handle, is tapped into the blue polamux directly.This instrument has been modified, likely by a third party, during its life and zimmer biomet cannot be held responsible for instruments that are repaired/modified outside design specification.A review of the complaint database has found no similar complaints reported with this item # / lot # combination.A review of the complaints data base for 3 years prior to the notification date has found no similar reported events for this item.The mhr related to the involved product has been reviewed and does not show any non-conformity, rejection or concession that could be related to the reported event.The product was most likely conforming when it left zimmer biomet control.Risk assessment: due to the instrument being modified and not to design specification, risk assessment cannot be assessed as the risk procedure does not cater for third party alterations to zimmer biomet design specifications.No corrective or preventive actions are deemed necessary at this time.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 surgery the trial bearing handle broke off.The surgeon removed the femur in order to remove the 5mm bearing trial.

• Brand Name: OXF TRIAL BEARING MED SZ 4/5
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 9161292
• MDR Text Key: 194388424
• Report Number: 3002806535-2019-00795
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2019
• 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: 32-420378
• Device Lot Number: 985220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1