MAUDE Adverse Event Report: SMITH & NEPHEW, INC. KNEE IMPLANT; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Device Problem Material Integrity Problem (2978)

Patient Problem Injury (2348)

Event Date 01/01/1901

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to wear.Liner and femoral head exchanged.Primary surgery performed in 2013.

Manufacturer Narrative

The devices, used in treatment, were not returned for evaluation and the reported event could not be confirmed.A clinical analysis confirmed per complaint details, the revision performed approximately 6 years post implantation was due to wear.No supporting clinical documentation was provided; therefore, a thorough medical investigation could not be performed.The patient impact beyond the reported component wear and revision could not be determined.No further medical assessment is warranted at this time.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 overuse or excessive pressure on the joint, injury, infection and/or patient condition.Without the return of the actual product involved and no patient medical records, our investigation of this report is inconclusive.

• Brand Name: KNEE IMPLANT
• Type of Device: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9311080
• MDR Text Key: 166021677
• Report Number: 1020279-2019-03947
• 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: company representative
• Type of Report: Initial,Followup
• Report Date: 08/31/2020

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
• Initial Date Manufacturer Received: 10/29/2019
• Initial Date FDA Received: 11/12/2019
• Supplement Dates Manufacturer Received: 08/21/2020
• Supplement Dates FDA Received: 08/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention