MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MI TRIAL FEM HEAD 36 +4; PROSTHESIS, KNEE, FEMOROTIBIAL, SMI-CONSTR, CEM, MET/POLY

Catalog Number	71369722
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/28/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during inspection it was noticed that the internal plastic connecting parts are chipped and misshapen due to normal use.No case involved.No patient injury.
Additional Manufacturer Narrative
The device, intended for use in treatment was not returned for evaluation, reporting event could not be confirmed.Therefore, product analysis could not be performed at this time.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.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.Without the return of the actual product involved, our investigation could not proceed.Should the devices or additional information be received, the complaints will be reopened.No further investigation warranted for these complaints; 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 +4
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, SMI-CONSTR, CEM, MET/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10097757
• Report Number: 1020279-2020-01884
• Device Sequence Number: 6166421
• Product Code: HRY
• UDI-Device Identifier: 03596010559937
• UDI-Public: 3596010559937
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2020

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
• Operator of Device: Health Professional
• Device Catalogue Number: 71369722
• Device Lot Number: UNKNOWN
• Distributor Facility Aware Date: 04/28/2020
• Initial Date Received by Manufacturer: 04/28/2020
• Supplement Date Received by Manufacturer: 08/21/2020
• Initial Report FDA Received Date: 05/28/2020
• Supplement Report FDA Received Date: 09/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1