MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS HIGH FLEXION INSERT SZ 7-8 9MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	71421522
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/04/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2012 a tka procedure was performed.Patient experience post-operative stiffness and a mua was performed to correct the issue.Slowly stiffness returned and a revision surgery was required to increase rom mainly into flexibility.Surgeon attributed stiffness to scarring and patella maltracking.A scar was performed to release, poly exchange and revised patella.Rom improved post-operative.
Additional Manufacturer Narrative
The affected genesis ii resurfacing patellar component, genesis ii oxinium p/s femoral component, genesis ii ps high flexion insert and genesis ii np tibial baseplate were not returned for evaluation.Therefore a product analysis could not be performed.However, device details were provided.Thus, a review of the manufacturing records and complaint history was conducted.The review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.The review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A relationship, if any, between the devices and the reported incident or adverse event could not be corroborated.A clinical evaluation noted that details regarding the patient¿s weight-bearing status, medical history, bone quality, fall/trauma history, and other additional clinical relevant information have not been provided.Based on the information provided, the future impact to the patient beyond the revision cannot be determined.Without the return of the actual products involved and no patient information available, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should the devices or additional information be received, the complaint will be reopened.
Additional Manufacturer Narrative
H11: correction on g5.Information was received on 6/30/2019.

• Brand Name: GII PS HIGH FLEXION INSERT SZ 7-8 9MM
• 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: 8787728
• Report Number: 1020279-2019-02678
• Device Sequence Number: 19413515
• Product Code: JWH
• UDI-Device Identifier: 03596010492975
• UDI-Public: 03596010492975
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K032295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/13/2019

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 Catalogue Number: 71421522
• Device Lot Number: 11ET07068
• Initial Date Received by Manufacturer: 06/30/2019
• Supplement Date Received by Manufacturer: 06/30/2019; 06/30/2019
• Initial Report FDA Received Date: 07/14/2019
• Supplement Report FDA Received Date: 07/14/2019; 09/13/2019
• 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