MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FEMORAL TRIAL IMPACTOR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	71440009
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/11/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery the instrument broke.No injury reported.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The device was manufactured in 2010.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.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.

• Brand Name: FEMORAL TRIAL IMPACTOR
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9419820
• Report Number: 1020279-2019-04302
• Device Sequence Number: 19263625
• Product Code: JDI
• UDI-Device Identifier: 00885556034736
• UDI-Public: 00885556034736
• Combination Product (Y/N): N
• PMA/510(K) Number: K123598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2020

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 Model Number: 71440009
• Device Catalogue Number: 71440009
• Device Lot Number: 10KM13361
• Initial Date Received by Manufacturer: 11/11/2019
• Supplement Date Received by Manufacturer: 05/14/2020
• Initial Report FDA Received Date: 12/05/2019
• Supplement Report FDA Received Date: 05/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1