MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII OVAL RESURFACING PAT 35MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	71421035
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/22/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
Arthrofibrosis right knee.Manipulation under anesthesia was performed for which subject was hospitalised.
Additional Manufacturer Narrative
The associated journey ii bcs femoral oxinium, journey ii bcs articular insert, journey tibial baseplate and genesis ii oval resurfacing patella were not returned for evaluation.Therefore a product analysis could not be performed.However, device details were provided.Thus, the review of manufacturing records was conducted which did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.There is no information that would suggest the implanted devices failed to meet specifications.A relationship, if any, between the devices and the reported incident or adverse event could not be corroborated.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A clinical evaluation noted that additional information was obtained which included limited information from the primary implantation.No x-rays were submitted.Root cause of the arthrofibrosis could be contributed to concomitant medical problems and history such as the noted arthroscopic partial medial meniscectomy + debridement cartilage right knee 1998, valgization osteotomy knee right 1998, screws tibia and resection synovial cyst right knee (b)(6) 2015, puncture right knee (b)(6) and the report that no physical rehabilitation was noted.Patient impact beyond the reported arthrofibrosis and mua procedure with a hospital stay is unknown.No further medical assessment is warranted based on the information provided.Without the return of the actual products involved, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the devices or additional information be received, the complaint will be reopened.

• Brand Name: GII OVAL RESURFACING PAT 35MM
• 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: 8536327
• Report Number: 1020279-2019-01635
• Device Sequence Number: 19265133
• Product Code: JWH
• UDI-Device Identifier: 03596010485076
• UDI-Public: 03596010485076
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2019

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: 01/03/2024
• Device Catalogue Number: 71421035
• Device Lot Number: 14CM01551
• Initial Date Received by Manufacturer: 04/01/2019
• Supplement Date Received by Manufacturer: 04/01/2019
• Initial Report FDA Received Date: 04/22/2019
• Supplement Report FDA Received Date: 07/29/2019
• 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