MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII DISHED INS SZ 5-6 9MM; PRSTHSS, KNEE, PTLLFMRTBIAL, SM-CNSTRND, CMNTD, POLYMER/METAL/POLYMER

Catalog Number	71420778
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Injury (2348); Fibrosis (3167)
Date of Event	04/23/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to instability, arthrofibrosis and excessive valgus angle.
Additional Manufacturer Narrative
The affected genesis ii dished insert, genesis ii cmt tibial baseplate and genesis ii oxinium femoral component were not returned for evaluation.A review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode.A clinical evaluation noted that without the supporting lab/pathology results, imaging, and/or the analysis of the explanted components, the root cause of the reported pain, arthrofibrosis, flexion instability, and excessive valgus angle cannot be confirmed and it cannot be concluded that the reported events were associated with a mal-performance of the implant.The patient impact beyond the pain, revision, and expected transient post-op convalescence period cannot be determined.No further clinical assessment is warranted at this time.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.Should the device or additional information be received, the complaint will be reopened.

• Brand Name: GII DISHED INS SZ 5-6 9MM
• Common Device Name: PRSTHSS, KNEE, PTLLFMRTBIAL, SM-CNSTRND, CMNTD, POLYMER/METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7921496
• Report Number: 1020279-2018-02041
• Device Sequence Number: 13905126
• Product Code: JWH
• UDI-Device Identifier: 03596010209382
• UDI-Public: 03596010209382
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2019

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: 09/09/2023
• Device Catalogue Number: 71420778
• Device Lot Number: 13JM07031
• 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: 03/01/2019
• 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: 48 YR