MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII NONPOROUS PS FEM SZ 3 RT; PROST, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLY/MET/POLY

Model Number	71420116
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/22/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that revision surgery was performed due to infection.
Additional Manufacturer Narrative
The devices, used in treatment, were not returned for evaluation and the reported event could not be confirmed.The medical investigation concluded that no supporting clinically relevant documentation was provided; therefore, a thorough medical investigation could not be performed.However, it was communicated that this ¿revision surgery was performed due to infection¿ and per the doctor ¿this revision was not caused by concerned device¿.The patient impact beyond the reported infection remains unknown.Should clinical documentation become available in the future, the clinical/medical task may be re-evaluated.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.Infection is a potential complication associated with any surgery.Some potential probable causes could include contamination, patient reaction or a post-operative healing issue.

• Brand Name: GII NONPOROUS PS FEM SZ 3 RT
• Common Device Name: PROST, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLY/MET/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9527899
• Report Number: 1020279-2019-04607
• Device Sequence Number: 18932286
• Product Code: JWH
• UDI-Device Identifier: 03596010206022
• UDI-Public: 03596010206022
• 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 Implanted Year: 2011
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2020

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 Model Number: 71420116
• Device Catalogue Number: 71420116
• Initial Date Received by Manufacturer: 12/03/2019
• Supplement Date Received by Manufacturer: 03/20/2020
• Initial Report FDA Received Date: 12/27/2019
• Supplement Report FDA Received Date: 03/29/2020
• 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
• Patient Age: 78 YR