MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY BCS PAT RESRF RD 38 MM STD; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	74024838
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/12/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after underwent a total knee arthroplasty for a study, the patient had delayed wound healing and possible infection.Revision surgery and drainage were performed with a poly exchange.The subject recovered from the event but was terminated from the study.The explanted device was destroyed.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A clinical evaluation was conducted and x-rays provided do not contribute to the reported wound infection.Based on the limited information provide and without the return of the explanted device for analysis the root cause of the reported delayed healing cannot be confirmed at this time but the circumstances reported of the delayed wound healing is a known complication of a surgical procedure and not a failure of the implant devices.Based on the lab results there was no indication of infection.The patient¿s medical history is significant for multiple comorbidities i.E.Diabetes which cannot be ruled out as possible contributing factors.The future impact to the patient beyond the revision cannot be determined.No further clinical/medical assessment is warranted at this time.A review of complaint history on the listed parts revealed no prior complaints for the listed batches with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.This included a review of sterilization documents which indicated that the product was sterilized according to sterilization release documentation.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: JRNY BCS PAT RESRF RD 38 MM STD
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8434683
• Report Number: 1020279-2019-01114
• Device Sequence Number: 14122055
• Product Code: JWH
• UDI-Device Identifier: 03596010554550
• UDI-Public: 03596010554550
• Combination Product (Y/N): N
• PMA/510(K) Number: K042515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,study,use
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2019

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 Catalogue Number: 74024838
• Device Lot Number: 18HM22837
• Initial Date Received by Manufacturer: 02/26/2019
• Supplement Date Received by Manufacturer: 02/26/2019
• Initial Report FDA Received Date: 03/19/2019
• Supplement Report FDA Received Date: 06/20/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 60 YR