MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG TRIAL FEMORAL HEAD 32 L/+8; PROSTHESIS, HIP, SEMI-CONSTRAIND, MET/CERAM/POLY, CEMNTD OR NON-POROUS, UNCEMENT

Model Number 75100852

Device Problem Deformation Due to Compressive Stress (2889)

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

Event Date 11/25/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that three trial femoral head 32 l/+8 were found broken.It is not known if all events are related to the same procedure.No injuries or surgical delays reported.

Manufacturer Narrative

It was reported that three trial femoral head 32 l/+8 ((b)(4)) were found broken.It is not known if all events are related to the same procedure.No injuries or surgical delays were reported.The devices, intended for use in treatment, were not returned for investigation.No product was returned for investigation and no batch number was communicated.The reported failure can therefore not be evaluated.Based on the available information, a thorough investigation cannot be conducted and the root cause of the reported issue remains undetermined.No further actions have been initiated.If the reported devices or additional information become available, this investigation will be reopened.Smith and nephew will continue to monitor the device for similar issues.This investigation is considered closed.

Manufacturer Narrative

The associated device, intended for use in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.One of the tabs on the device is fractured, rendering it inoperable.The device shows signs of extensive use.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: TRIAL FEMORAL HEAD 32 L/+8
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAIND, MET/CERAM/POLY, CEMNTD OR NON-POROUS, UNCEMENT
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 11060987
• MDR Text Key: 223377468
• Report Number: 9613369-2020-00267
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07611996121858
• UDI-Public: 07611996121858
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 06/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 75100852
• Device Catalogue Number: 71369717
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2021
• Initial Date Manufacturer Received: 11/26/2020
• Initial Date FDA Received: 12/22/2020
• Supplement Dates Manufacturer Received: 12/24/2020; 06/17/2021
• Supplement Dates FDA Received: 01/16/2021; 06/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1