MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS HIGH FLEXION INSERT SZ 1-2 15MM; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,POLYMER/METAL/POLY

Catalog Number	71421504
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	02/09/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a revision surgery to swap to a constrained liner due femur dislocation after a fall.Femur and tibia were also replaced.Surgeon trialed the appropriate thickness of constrained liner and all definitive implants inserted.There was good range of motion, stability and soft tissue balance.
Additional Manufacturer Narrative
The associated genesis ii ps high flexion insert was not returned for evaluation.A clinical investigation noted that no supporting clinical/medical documents have been provided.Therefore a thorough investigation cannot be performed.Our investigation included a review of the manufacturing records for the listed batch which did not reveal any deviation from the standard manufacturing processes.A review of complaint history on the listed part revealed no prior complaints for this failure mode with the same batch number.Without the return of the actual product 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.We consider this investigation closed.Should additional information be received, the complaint will be reopened.

• Brand Name: GII PS HIGH FLEXION INSERT SZ 1-2 15MM
• Common Device Name: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,POLYMER/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7321043
• Report Number: 1020279-2018-00272
• Device Sequence Number: 13480295
• Product Code: JWH
• UDI-Device Identifier: 03596010493774
• UDI-Public: 03596010493774
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K032295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2018

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: 02/18/2020
• Device Catalogue Number: 71421504
• Device Lot Number: 10BT39353
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/11/2018
• Supplement Date Received by Manufacturer: 02/11/2018
• Initial Report FDA Received Date: 03/07/2018
• Supplement Report FDA Received Date: 05/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FEMORAL PART: 71421014 LN: 13LM04336; TIBIAL PART: 71420162 LN: 13KT35392
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention