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
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/29/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient had a revision surgery performed due to metallosis and insert wear.
Additional 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
• Common Device Name: 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
• Report Number: 1020279-2020-00108
• Device Sequence Number: 2133261
• Product Code: JWH
• UDI-Device Identifier: 03596010555076
• UDI-Public: 03596010555076
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K042515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2020

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 12/06/2019
• Supplement Date Received by Manufacturer: 04/13/2020
• Initial Report FDA Received Date: 01/06/2020
• Supplement Report FDA Received Date: 04/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention