MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURN ART INS BCS STD 3-4 LT10; PRSTHSS, KNEE, PTLLFMRTBIAL, SM-CNSTRND, CMNTD, POLYMER/METAL/POLYMER

Model Number 74023242

Device Problem Degraded (1153)

Patient Problem Injury (2348)

Event Date 11/29/2018

Event Type  Injury  

Event Description

It was reported that patient had a revision surgery performed due to metallosis and insert wear.

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 it is reported that this patient underwent a tka revision due to pain, loosening and metallosis.The surgeon noted that metallosis was found and the synovium was completely black with aggressive synovitis at the tibial plateau, causing a loosening.There was no metal-metal contact or other conflict with a hard surface such as cement.Polyethylene was not broken but seemed more used than what we could expect.No records have been provided.X-rays and additional information have been provided, which indicates an aspiration was performed prior to the tka revision.The intraoperative findings of metallosis, synovitis and loosening are consistent with findings associated with metal debris.Without the supporting lab/pathology results and the analysis of the explanted components, the source of the reported metallosis cannot be confirmed.It cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.No further clinical assessment is warranted at this time.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.Some potential probable causes could include patient reaction or a post-operative healing 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.

• Brand Name: JOURN ART INS BCS STD 3-4 LT10
• Type of Device: PRSTHSS, KNEE, PTLLFMRTBIAL, SM-CNSTRND, CMNTD, POLYMER/METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9551101
• MDR Text Key: 173772852
• Report Number: 1020279-2020-00108
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 03596010555076
• UDI-Public: 03596010555076
• Combination Product (y/n): N
• PMA/PMN Number: K042515
• 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: 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/11/2019
• Device Model Number: 74023242
• Device Catalogue Number: 74023242
• Device Lot Number: 09CM10464
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention