MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II CR FEM OX NP RT SZ 7; PRSTHS,KNEE,PATELLOFEMRTIBIL,SMICONSTRAIND,CMNTD,POLYMR/METL/POLYMR

Catalog Number	74021157
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/13/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented arthrofibrosis in the right knee.Event treatment included surgery/procedure.
Additional Manufacturer Narrative
The associated complaint devices were not returned for evaluation.Our investigation including a review of complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.A review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A clinical analysis noted that no relevant supporting documentation was provided for inclusion in this medical investigation.Therefore, no further medical assessment is warranted at this time.Without the return of the actual product involved, our investigation of this report is inconclusive.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: JRNY II CR FEM OX NP RT SZ 7
• Common Device Name: PRSTHS,KNEE,PATELLOFEMRTIBIL,SMICONSTRAIND,CMNTD,POLYMR/METL/POLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7805394
• Report Number: 1020279-2018-01573
• Device Sequence Number: 13775673
• Product Code: JWH
• UDI-Device Identifier: 00885556422823
• UDI-Public: 00885556422823
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,study
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2018

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 Catalogue Number: 74021157
• Device Lot Number: 18CM09702
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/24/2018
• Supplement Date Received by Manufacturer: 07/24/2018
• Initial Report FDA Received Date: 08/22/2018
• Supplement Report FDA Received Date: 11/28/2018
• 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: Other
• Patient Age: 71 YR