MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY BCS II FEMORAL OXIN RT SZ 6; PRSTHSS,KNE,PTLLFMRTBL,SMCNSTRND,CMNTD,PLYMRMTLPLYMR

Model Number	OR74022116
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/07/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a medical intervention was performed for right knee arthroscopic synovectomy and hypertrophic scar removal.
Additional Manufacturer Narrative
The associated complaint devices were not returned for evaluation.A review of complaint history revealed no prior complaints for the listed lots with the same failure modes.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.Our clinical/medical investigation concluded, based on the available information and observations, during the arthroscopic exam the hypertrophic tricompartmental scar was a complication of the procedure and not a prosthesis failure.The patient remains in the journey ii retrospective study at this time.Without the actual products involved, our investigation cannot proceed.If the devices 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 II FEMORAL OXIN RT SZ 6
• Common Device Name: PRSTHSS,KNE,PTLLFMRTBL,SMCNSTRND,CMNTD,PLYMRMTLPLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7337825
• Report Number: 1020279-2018-00316
• Device Sequence Number: 13823816
• Product Code: JWH
• UDI-Device Identifier: 00885556169964
• UDI-Public: 00885556169964
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2018

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: 12/16/2022
• Device Model Number: OR74022116
• Device Catalogue Number: OR74022116
• Device Lot Number: 12MM10535
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/21/2018
• Supplement Date Received by Manufacturer: 02/21/2018
• Initial Report FDA Received Date: 03/14/2018
• Supplement Report FDA Received Date: 05/10/2018
• 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: 64 YR