MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN PS HIGH FLEX XLPE SZ 5-6 9MM; PRSTHSS,KNEE,PATLLFMRTIBIL,SMI-CNSTRIND,CMNTD, PLYMR/MTL/PLYMR

Model Number 71453221

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Injury (2348)

Event Date 11/18/2019

Event Type  Injury  

Event Description

It was reported that the patient has components in place since (b)(6) 2015 and was experiencing stiffness, a revision surgery was performed and everything was removed except the patella.

Manufacturer Narrative

The devices, used in treatment, were not returned for evaluation and the reported event could not be confirmed.The medical investigation concluded that, per communications, no relevant clinical information will be provided.Without the requested clinical/medical information, a thorough investigation cannot be rendered.Should any additional medical information be provided this complaint will be re-assessed.A review of complaint history did not reveal additional complaints for the listed batches.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.Some potential probable causes of this event could include an alignment or fit/ sizing issue.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 complaints will be reopened.No further investigation is warranted for these complaints; however, we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: LGN PS HIGH FLEX XLPE SZ 5-6 9MM
• Type of Device: PRSTHSS,KNEE,PATLLFMRTIBIL,SMI-CNSTRIND,CMNTD, PLYMR/MTL/PLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9471038
• MDR Text Key: 170854279
• Report Number: 1020279-2019-04397
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00885556035337
• UDI-Public: 00885556035337
• Combination Product (y/n): N
• PMA/PMN Number: K071071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 03/09/2020

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: 71453221
• Device Catalogue Number: 71453221
• Device Lot Number: 15AM01947
• Initial Date Manufacturer Received: 11/18/2019
• Initial Date FDA Received: 12/15/2019
• Supplement Dates Manufacturer Received: 03/03/2020
• Supplement Dates FDA Received: 03/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention