MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY BCS PAT RESRF RD 29 MM STD; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Model Number	OR74024829
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/11/2013
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a complete synovectomy was performed due to an hematogenously spread acute deep sepsis and all total knee implants were replaced with implantation of antibiotic impregnated spacer.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A clinical evaluation was conducted and without the supporting lab/pathology results, imaging, and/or the analysis of the explanted components, the root cause of the reported cellulitis and hematogenously spread of the acute deep sepsis cannot be confirmed however, based on the reports of multiple surgeries and interventions the reported ongoing infection was the cause for revision and infections as described are not usually a result of product failures or sterility issues of the device.There is no evidence to support our device contributed to the reported infection.The major contributing factor to the reported knee popping is due to a fall the patient sustained and is not due to a mal-performance of the prosthetic components.Without the return of the device for evaluation the root cause of the reported failed total knee arthroplasty cannot be concluded.However based on the medical records the patient has sustained multiple falls which cannot be ruled out as contributing factors.The patient impact beyond the revision itself cannot be concluded.No further medical assessment is possible at this time based on the information provided.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 29 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: 8348739
• Report Number: 1020279-2019-00662
• Device Sequence Number: 1923288
• Product Code: JWH
• UDI-Device Identifier: 03596010554529
• UDI-Public: 03596010554529
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K042515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2019

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 Expiration Date: 07/10/2020
• Device Model Number: OR74024829
• Device Catalogue Number: OR74024829
• Device Lot Number: 10GM06523
• Initial Date Received by Manufacturer: 01/28/2019
• Supplement Date Received by Manufacturer: 01/28/2019
• Initial Report FDA Received Date: 02/18/2019
• Supplement Report FDA Received Date: 06/17/2019
• 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: 69 YR