MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII OXIN P/S FEM LEFT SZ 6; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71421016
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/15/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a tkr surgery had been performed on (b)(6) 2018, the patient presented stiffness.The adverse event was addressed with a revision surgery on (b)(6) 2021 to replace the gns ii cmt tib size 5 left (case-(b)(4)), gii oxin p/s fem left sz 6 (case-(b)(4)) and lgn ps high flex xlpe sz 5-6 9mm (case-(b)(4)).The condition of the patient is unknown.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation.The pictures provided were reviewed and could not confirm the stated failure mode.The clinical/medical investigation concluded that, the requested surgical records and x-rays are unavailable.Without the requested surgical records and x-rays, the clinical root cause of the stiffness cannot be concluded.The patient impact beyond the revision cannot 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.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes could be alignment, fit/size of device used or wear.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.We consider this investigation closed.

• Brand Name: GII OXIN P/S FEM LEFT SZ 6
• 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: 11797672
• Report Number: 1020279-2021-03907
• Device Sequence Number: 3080889
• Product Code: JWH
• UDI-Device Identifier: 03596010469229
• UDI-Public: 03596010469229
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K962557
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2021

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: 71421016
• Device Catalogue Number: 71421016
• Device Lot Number: 17JM12997
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/15/2021
• Supplement Date Received by Manufacturer: 07/12/2021
• Initial Report FDA Received Date: 05/10/2021
• Supplement Report FDA Received Date: 07/13/2021
• 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