MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRL 12/14 TPR FEM HD 32 -3; PRSTHSISKNEEFMORTIBLSMICNSTRINDCMNTDMTALPOLYMR

Model Number 71353203

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Date 02/10/2020

Event Type  Injury  

Event Description

It was reported that during a tha procedure, flange that approximates with trunnion on femoral stem broke off.The trial head does not fit securely without this plastic flange.Length of delay unknown.S&n backup device available.No impact or injury to patient reported.

Manufacturer Narrative

The device, used in treatment was not returned for evaluation, reporting event could not be confirmed.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 actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: TRL 12/14 TPR FEM HD 32 -3
• Type of Device: PRSTHSISKNEEFMORTIBLSMICNSTRINDCMNTDMTALPOLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9792467
• MDR Text Key: 182143296
• Report Number: 1020279-2020-00788
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 03596010198297
• UDI-Public: 03596010198297
• Combination Product (y/n): N
• PMA/PMN Number: K121393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 71353203
• Device Catalogue Number: 71353203
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/11/2020
• Initial Date FDA Received: 03/05/2020
• Supplement Dates Manufacturer Received: 05/26/2020
• Supplement Dates FDA Received: 06/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention