MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MI TRIAL FEM HEAD 36 -3; PROSTHESIS,KNEE,FEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,METAL/POLYMER

Model Number 71343603

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 06/28/2021

Event Type  malfunction  

Event Description

It was reported that after visual inspection of the device mi trial fem head 36 -3 it was confirmed that one of the tabs broke off the device, rendering it inoperable.

Manufacturer Narrative

The device, intended for use in treatment, was returned for evaluation.A visual inspection of the return product confirms multiple scratches burrs and deep gouges in the plastic on the outer and inner surface of the trial.Also the visual confirms two of the inner tabs are broken off, confirming the stated failure mode.The broken pieces were not returned.The date of manufacture is unknown for this part.This device shows signs of excessive wear/usage.The device is a reusable instrument that can be exposed to numerous surgeries and cleaning cycles.As plastics are vulnerable and crack may have initiated during use and possible causes could be due to the heating and cooling associated with autoclaving or prolonged use.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.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 warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: MI TRIAL FEM HEAD 36 -3
• Type of Device: PROSTHESIS,KNEE,FEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12746179
• MDR Text Key: 281205746
• Report Number: 1020279-2021-07815
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 03596010000675
• UDI-Public: 03596010000675
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/03/2021

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: 71343603
• Device Catalogue Number: 71369720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2021
• Initial Date Manufacturer Received: 10/20/2021
• Initial Date FDA Received: 11/03/2021
• Supplement Dates Manufacturer Received: 10/20/2021
• Supplement Dates FDA Received: 11/03/2021
• 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: A
• Patient Sequence Number: 1