MAUDE Adverse Event Report: SMITH & NEPHEW, INC. KNEE IMPLANT; PRSTHSS,KN,PTLLFMRTBL,SM-CNSTRND,CMNTD,PLYMR/MTL

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Injury (2348)

Event Date 12/24/2019

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to falling of insert and incompatibility.

Manufacturer Narrative

New information:d10,g4,h1,h2,h3,h6,h7,h11.Results of investigation: the device, used in treatment, were not returned for evaluation.A clinical analysis indicated that this complaint from japan reports a revision secondary to ¿falling of insert and incompatibility¿.No clinical/medical documents were provided for this investigation.Without supporting clinical/medical documents, a thorough investigation cannot be performed.Should information become available this complaint can be re-assessed.The impact to the patient beyond the surgery and recovery cannot be concluded.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors and/or some potential probable causes that could contribute to the reported event have been identified as but not limited to traumatic injury, surgical technique, implant failure or design of device.Without the return of the actual product involved and no patient medical records, our investigation of this report is inconclusive.Based on this investigation, the need for corrective action is not indicated.No further investigation 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.We consider this investigation closed.

• Brand Name: KNEE IMPLANT
• Type of Device: PRSTHSS,KN,PTLLFMRTBL,SM-CNSTRND,CMNTD,PLYMR/MTL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9580184
• MDR Text Key: 174659070
• Report Number: 1020279-2020-00219
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 10/20/2020

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/26/2019
• Initial Date FDA Received: 01/13/2020
• Supplement Dates Manufacturer Received: 10/15/2020
• Supplement Dates FDA Received: 10/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention