MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY FEM OX NP BCS RT SZ 6; PRSTHSS, KNEE, PTLLFMRTBIAL, SM-CNSTRND, CMNTD, POLYMER/METAL/POLYMER

Catalog Number	74021116
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/02/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an arthroscopy was performed to have scar tissue of the suprapatellar pouch resected.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A clinical analysis indicated that without imaging and/or analysis of the explanted components, the root cause of the fractured posts cannot be concluded.However, the reported history of arthrofibrosis, persistent itbs, the ¿kneeling episode¿/hyperflexion with subsequent pain and ¿acute clunking of the right knee¿ along with the 5.5 months continued ambulation prior to the right revision cannot be ruled out as contributing factors to the post deformation/fracture/¿failed knee¿ and subsequent right tka revision.Also, based on the required increased insert thickness, left knee laxity could have been a contributing factor to the left poly subluxation and/or post fracture and subsequent revision.The patient impact beyond the reported symptoms and bilateral knee revisions cannot be determined.No further medical assessment is warranted at this time.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the listed parts did not reveal additional complaints for the listed batches.Without the actual product involved our investigation cannot proceed.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate further as necessary.If the devices are received in the future, this complaint can be re-opened.We consider this complaint closed.

• Brand Name: JOURNEY FEM OX NP BCS RT SZ 6
• 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: 7730103
• Report Number: 1020279-2018-01444
• Device Sequence Number: 19173769
• Product Code: JWH
• UDI-Device Identifier: 03596010554086
• UDI-Public: 03596010554086
• 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: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2018

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: 07/28/2016
• Device Catalogue Number: 74021116
• Device Lot Number: 06GM12362
• Initial Date Received by Manufacturer: 05/21/2018
• Supplement Date Received by Manufacturer: 05/21/2018
• Initial Report FDA Received Date: 07/29/2018
• Supplement Report FDA Received Date: 12/16/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Weight: 99