MAUDE Adverse Event Report: SMITH AND NEPHEW, INC. GII PS HI FLEX ISRT SZ 7-8 11; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71421523
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Intraoperative Pain (2662)
Date of Event	08/06/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that revision surgery was performed due to anterior base left knee pain.
Additional Manufacturer Narrative
The associated complaint devices were returned and evaluated.The clinical/medical team concluded, without the radiographic images and the explanted device for evaluation the root cause of the anterior base pain referenced in (b)(6) cannot be concluded.However, the reported anterior knee pains not an uncommon occurrence after a tka.We are unable to rule out the length of time in-situ, the patient¿s complex medical history, and the patient¿s reported fall hx as contributing factors or the patella which was then resurfaced.In addition, we are unable to determine a causal relationship between the procedure to implant the smith and nephew device and the performance of the smith and nephew device.For (b)(6) and (b)(6) it was concluded: according to the genesis ii surgical technique, a wound hematoma is a possible adverse effect of a tka.Additionally, the root cause of the 3 to 4 cm in length ripped opening of the patient¿s deep fascial tissues cannot be determined.However, a procedural related event cannot be ruled out as a possible contributing factor.For (b)(6) and (b)(6) -- (b)(6) 2016 it was concluded: based on ultrasound finding and with limited information provided, the root cause of the bilateral lower extremity pain and edema cannot be determined.It is unknown if the patient is still experiencing these symptoms or if any medical interventions have been performed to alleviate or treat the reported issues.The impact to the patient beyond these symptoms cannot be concluded.No further clinical/medical assessment is warranted 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/failure mode.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.

• Brand Name: GII PS HI FLEX ISRT SZ 7-8 11
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH AND NEPHEW, INC.; 1450 brooks road; memphis, tennessee; memphis 38116
• MDR Report Key: 7924486
• Report Number: 1020279-2018-02021
• Device Sequence Number: 1526686
• Product Code: JWH
• UDI-Device Identifier: 03596010492982
• UDI-Public: 03596010492982
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K032295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2019

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: 05/06/2019
• Device Catalogue Number: 71421523
• Device Lot Number: 09EM05880
• 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: 02/08/2019
• 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
• Patient Age: 74 YR