MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII C/R ART INS SZ 1-2 9MM; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTED,POLYMERMETALPOLYMER

Catalog Number	71420480
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Injury (2348)
Date of Event	11/01/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to bone fracture.Only insert was replaced.
Additional Manufacturer Narrative
The associated complaint devices were not returned.The clinical/medical team concluded, without supporting clinical/medical documents a thorough investigation cannot be performed.Should information become available this complaint can be re-assessed.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.

• Brand Name: GII C/R ART INS SZ 1-2 9MM
• Common Device Name: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTED,POLYMERMETALPOLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8114676
• Report Number: 1020279-2018-02629
• Device Sequence Number: 1501064
• Product Code: JWH
• UDI-Device Identifier: 03596010207845
• UDI-Public: 03596010207845
• 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: 2000
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2019

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: 71420480
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 11/01/2018
• Supplement Date Received by Manufacturer: 11/01/2018
• Initial Report FDA Received Date: 11/29/2018
• Supplement Report FDA Received Date: 05/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71420036/UNKNOWN; 71420194/UNKNOWN; 71420566/UNKNOWN; 71420036/UNKNOWN; 71420194/UNKNOWN; 71420566/UNKNOWN
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention