MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII CR POLY TB SZ4 9MM LT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71420248
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Injury (2348)
Date of Event	03/30/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient underwent a total knee arthroplasty to her left knee on (b)(6) 2016.After replacement patient experienced severe pain, discomfort, and suffered injuries requiring a revision surgery on (b)(6) 2017 to remove and replace the implants.Patient had a second revision surgery performed on her left knee on (b)(6) 2017.
Additional Manufacturer Narrative
The associated complaint devices were not returned.The clinical/medical team concluded, no clinical relevant documents were provided to conduct a thorough medical assessment.No medical assessment is warranted at this time.This complaint will be re-evaluated if more information becomes available.A review of complaint history for the listed part revealed no prior complaints for the listed batch.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.Without the actual device involved our investigation cannot proceed.If the device or new information is received in the future, the complaints can be re-opened.No further actions are being taken at this time.We consider this investigation closed.
Event or Problem Description
It was reported that patient underwent a total knee arthroplasty to her left knee on (b)(6), 2016.After replacement patient experienced severe pain, discomfort, progressive osteolysis, and tibial component loosening, requiring a medically indicated revision surgery on (b)(6), 2017.During revision surgery the tibial baseplate and the insert were explanted and replaced for new devices.

• Brand Name: GII CR POLY TB SZ4 9MM LT
• 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: 8040449
• Report Number: 1020279-2018-02378
• Device Sequence Number: 19228754
• Product Code: JWH
• UDI-Device Identifier: 03596010206671
• UDI-Public: 03596010206671
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/23/2021

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 Model Number: 71420248
• Device Catalogue Number: 71420248
• Initial Date Received by Manufacturer: 10/11/2018
• Supplement Date Received by Manufacturer: 10/11/2018; 10/11/2018; 09/23/2021
• Initial Report FDA Received Date: 11/05/2018
• Supplement Report FDA Received Date: 12/27/2019; 09/14/2021; 09/23/2021
• 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: 71420578/UNKNOWN; 71420578/UNKNOWN
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 66 YR