MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII C/R HA POROUS FEM SZ 7LT; PRSTHSS,KNEE,PTLL/FMRTBL,SM-CNSTRND,UNCMNTD,PRS,CTD,PLYMR/MTL/PLYMR

Model Number 71422050

Device Problem Scratched Material (3020)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/01/2020

Event Type  malfunction  

Event Description

It was reported that during the procedure of bilateral tkr the implant was scratch.The surgeon had the option of placing a the oxonium implant (backup from smith+nephew), but it decided to finish the procedure with the implant scratched.The procedure had a delay between 0-30 min.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history did not reveal additional complaints for the listed batch.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Damage from improper handling is a likely probable cause of the reported event.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 device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: GII C/R HA POROUS FEM SZ 7LT
• Type of Device: PRSTHSS,KNEE,PTLL/FMRTBL,SM-CNSTRND,UNCMNTD,PRS,CTD,PLYMR/MTL/PLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10339303
• MDR Text Key: 200831366
• Report Number: 1020279-2020-03565
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 03596010496324
• UDI-Public: 03596010496324
• Combination Product (y/n): N
• PMA/PMN Number: K030612
• 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: 09/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71422050
• Device Catalogue Number: 71422050
• Device Lot Number: 16GM10149A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1