MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GENII NP TIB BASE SZ4 RT W/O; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71926241
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/29/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that revision surgery was performed due to significant pain and instability.Liner, tibial and femoral removed.
Additional Manufacturer Narrative
The associated complaint devices were not returned.The clinical/medical team concluded, based on the documentation provided, the root cause of the reported early onset pain and instability cannot be concluded; however currently unable to rule out the patient¿s lupus, possible soft tissue laxity and/or ligament imbalance over the follow-up 6 years and possible initial insert thickness as potential contributing factors the reported event as the implants pre-revision were reportedly in excellent position and alignment with good cement mantle and centrally tracking patella and the insert thickness doubled for the revision procedure.The patient impact beyond the reported early onset of pain, the noted pre-revision instability, and the revision surgery with an expected brief post-operative rehabilitation phase cannot be concluded.No further medical assessment can be rendered at this time.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed part revealed no prior complaints for the listed batch.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.We consider this investigation closed.

• Brand Name: GENII NP TIB BASE SZ4 RT W/O
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7923429
• Report Number: 1020279-2018-02054
• Device Sequence Number: 1539662
• Product Code: JWH
• UDI-Device Identifier: 00885556044551
• UDI-Public: 00885556044551
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K071071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2019

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: 11/05/2020
• Device Catalogue Number: 71926241
• Device Lot Number: 10EM08550
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/05/2018
• Supplement Date Received by Manufacturer: 09/05/2018
• Initial Report FDA Received Date: 10/01/2018
• Supplement Report FDA Received Date: 04/03/2019
• 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