MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRL 12/14 TPR FEM HD 32 -3; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number OR71353203

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/20/2019

Event Type  malfunction  

Event Description

It was reported that two pieces of inner collar broke off.Occurred inside of patient, all pieces were recovered.S&n backup device was available and was used to complete the surgery.No patient affectation, no pictures available, no closure letter needed, lot number is not on item.

Manufacturer Narrative

The associated complaint device was returned to be evaluated.The visual inspection confirms two of connections tabs are broken off the device.The broken pieces were not returned.The device has multiple burrs/gouges/scratches.This device shows signs of extreme wear/usage.The device has no available lot number.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: TRL 12/14 TPR FEM HD 32 -3
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9220414
• MDR Text Key: 163207097
• Report Number: 1020279-2019-03701
• 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,health
• Type of Report: Initial,Followup
• Report Date: 11/08/2019

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 Catalogue Number: OR71353203
• Device Lot Number: UNKNOWN/UNREADABLE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2019
• Initial Date Manufacturer Received: 09/23/2019
• Initial Date FDA Received: 10/22/2019
• Supplement Dates Manufacturer Received: 11/01/2019
• Supplement Dates FDA Received: 11/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1