MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II RESURF PAT 29MM; PROSTHSIS,KNEE,PATLLOFEMOROTIBIL,SMICONSTRAIND,CMNTD,POLYMR/METL/POLYMR

Catalog Number	71420574
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/11/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient primary surgery was on (b)(6) 2018.Pain is not decreasing and the range of movement was reduced.She is not able to extend or bend the knee.Patient has taken constant physical therapy but with no improvement.The doctor suggest another surgery to remove excessive scar tissue that was built up around the knee joint, but the outcome is the same, no range of motion and pain.
Additional Manufacturer Narrative
The associated complaint devices were not returned for evaluation.A clinical assessment noted the clinical information provided is insufficient to provide a thorough medical investigation.No medical assessment is warranted at this time.This complaint will be re-evaluated if more information becomes available.Our investigation including a review of complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.A review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Without the actual product involved, our investigation of this report is inconclusive.This investigation could not verify or identify any evidence of product contribution to the reported problem.If the device or new information is received in the future, this complaint can be re-opened.We consider this investigation closed.

• Brand Name: GNS II RESURF PAT 29MM
• Common Device Name: PROSTHSIS,KNEE,PATLLOFEMOROTIBIL,SMICONSTRAIND,CMNTD,POLYMR/METL/POLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7708353
• Report Number: 1020279-2018-01340
• Device Sequence Number: 16392765
• Product Code: JWH
• UDI-Device Identifier: 03596010208293
• UDI-Public: 03596010208293
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2019

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: 71420574
• Device Lot Number: 17JM10945
• Initial Date Received by Manufacturer: 07/03/2018
• Supplement Date Received by Manufacturer: 07/03/2018
• Initial Report FDA Received Date: 07/20/2018
• Supplement Report FDA Received Date: 01/30/2019
• 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: Required Intervention
• Patient Age: 54 YR