MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS HI FLEX ISRT SZ 7-8 11; PRSTHSS, KNEE, PTLLFMRTBIAL, SM-CNSTRND, CMNTD, POLYMER/METAL/POLYMER

Catalog Number	71421523
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	09/04/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient fell and injured his right knee.He didn't seek medical assistance for 12 months.Within that time, the tibial base plate has progressively gone into varus causing pain.Doctor believes that the patient fractured under the tibial tray in their fall which caused the tibial tray to fall into varus.
Additional Manufacturer Narrative
The associated complaint devices were not returned.The clinical / medical investigation concluded that no clinically relevant documentation was provided, therefore, a thorough medical investigation could not be performed.However, it was reported that the surgeon does not fault the implants, as the revision is believed to be due to a traumatic fall and fracture approximately 1 year ago with subsequent progression of pain and varus orientation of the tibial tray.The patient impact beyond the reported pain, revision tka and expected post-op rehabilitation period cannot be determined.No further medical assessment is warranted at this time.Without the actual product involved and/or device information, our investigation cannot proceed.If the devices or new information is received in the future, these complaints can be re-opened.No further actions are being taken at this time.

• Brand Name: GII PS HI FLEX ISRT SZ 7-8 11
• 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: 7921504
• Report Number: 1020279-2018-01938
• Device Sequence Number: 1526766
• Product Code: JWH
• UDI-Device Identifier: 03596010492982
• UDI-Public: 03596010492982
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K032295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care 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 Catalogue Number: 71421523
• Initial Date Received by Manufacturer: 09/04/2018
• Supplement Date Received by Manufacturer: 09/04/2018
• 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