MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS HI FLEX ISRT SZ 3-4 21; PRSTHSS,KNEEL,SEMI-CONSTRNED,CMNTD,POLYMER/METAL/POLYMER

Catalog Number	71421513
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/13/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a surgical intervention was performed due to pain and instability.Surgeon opened knee, removed poly and punched the tibia to check how well fixed.Baseplate was loose and easily removed with no cement attached.
Additional Manufacturer Narrative
The associated genesis ii ps hi flexion insert was not returned for evaluation.Our investigation included a review of the manufacturing records for the listed batch which did not reveal any deviation from the standard manufacturing processes.A review of complaint history on the listed part revealed no additional complaints for this failure mode with the same batch number.A clinical evaluation performed in this investigation concluded that based on the available information, the root cause for this patient¿s pain and the instability of her knee cannot be concluded but were likely related to the loosened tibial base plate.The current status of the patient has not been provided 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.We consider this investigation closed.Should additional information be received, the complaint will be reopened.

• Brand Name: GII PS HI FLEX ISRT SZ 3-4 21
• Common Device Name: PRSTHSS,KNEEL,SEMI-CONSTRNED,CMNTD,POLYMER/METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7136095
• Report Number: 1020279-2017-01314
• Device Sequence Number: 1450512
• Product Code: JWH
• UDI-Device Identifier: 03596010493811
• UDI-Public: 03596010493811
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K032295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2018

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: 12/01/2024
• Device Catalogue Number: 71421513
• Device Lot Number: 14MM03993
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/13/2017
• Supplement Date Received by Manufacturer: 12/13/2017
• Initial Report FDA Received Date: 12/20/2017
• Supplement Report FDA Received Date: 05/18/2018
• 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: Other; Required Intervention