MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII P/S ALL POLY TB SZ5 9MM LT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71420384
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after tka, a second stage revision was performed on (b)(6) 2021 to remove the poly tibia and cobalt chrome femur.The current health status of patient is unknown.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per email correspondence, the requested surgical records and x-rays are unavailable.Without the requested surgical records and x-rays, neither the clinical root cause of the revision, nor the patient impact beyond the revision can be determined.No further medical assessment can be rendered at this time.Should additional clinically relevant documentation become available the medical investigation task may be re-evaluated.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history did not reveal additional complaints for the listed batch.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.No details of the alleged fault, malfunction or injury were provided, therefore no probable cause can be delineated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: GII P/S ALL POLY TB SZ5 9MM LT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11815834
• Report Number: 1020279-2021-04124
• Device Sequence Number: 3911140
• Product Code: JWH
• UDI-Device Identifier: 03596010207357
• UDI-Public: 03596010207357
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K953274
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71420384
• Device Catalogue Number: 71420384
• Device Lot Number: 17GM14244
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/20/2021
• Supplement Date Received by Manufacturer: 09/03/2021
• Initial Report FDA Received Date: 05/12/2021
• Supplement Report FDA Received Date: 09/09/2021
• 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