MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII NONPOROUS P/S FEM SZ 4 LT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number	71420102
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	10/19/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent revision surgery due to an infection.Femoral component was removed.
Additional Manufacturer Narrative
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 complaint details, a revision surgery was performed due to infection.Reportedly, "the doctor says the devices were not defective".It was communicated that the requested medical documentation/information is not available for inclusion in the medical investigation.Based on the limited information provided, the root cause of the revision was the reported infection, although the source of infection remains unknown.The patient impact beyond the reported infection and subsequent revision could not be determined.No further medical assessment is warranted at this time.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.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.Possible causes could include but not limited to contamination, patient reaction, post-operative healing issue, traumatic injury, joint tightness, material in use, or loss of sterility.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 NONPOROUS P/S FEM SZ 4 LT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10848271
• Report Number: 1020279-2020-06495
• Device Sequence Number: 4135528
• Product Code: JWH
• UDI-Device Identifier: 03596010205957
• UDI-Public: 03596010205957
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2021

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 71420102
• Device Catalogue Number: 71420102
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 10/19/2020
• Supplement Date Received by Manufacturer: 06/28/2021
• Initial Report FDA Received Date: 11/16/2020
• Supplement Report FDA Received Date: 06/28/2021
• 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