MAUDE Adverse Event Report: SMITH & NEPHEW, INC. G2 CONST INSRT SZ1-2 15MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	71420964
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	12/04/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient fell which caused a complete patellar tendon tear and dislocation/subluxation of the knee implant.
Additional Manufacturer Narrative
The associated complaint device was returned and evaluated.The lab analysis concluded, the visual inspection showed scratches on the articulating and non-articulating surfaces of the insert.There is no other major damage or wear present.There were no observations of material or manufacturing deviations in the course of this investigation.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the part revealed no prior complaints for the listed batch.The clinical/medical team concluded, no clinically relevant documentation was provided, therefore a thorough medical investigation could not be performed.However, the complaint details noted the root cause of the revision was the patient fall and subsequent patellar tendon tear/dislocation of the knee implant.The patient status remains unknown.Should clinical documentation become available, the clinical/medical investigation may be re-evaluated.No further medical assessment is warranted at this time.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.This investigation is closed.

• Brand Name: G2 CONST INSRT SZ1-2 15MM
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8200920
• Report Number: 1020279-2018-02925
• Device Sequence Number: 19353117
• Product Code: JWH
• UDI-Device Identifier: 03596010210128
• UDI-Public: 03596010210128
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K962137
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2019

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 Expiration Date: 02/13/2021
• Device Catalogue Number: 71420964
• Device Lot Number: 11BM10015
• Initial Date Received by Manufacturer: 12/04/2018
• Supplement Date Received by Manufacturer: 12/04/2018
• Initial Report FDA Received Date: 12/27/2018
• Supplement Report FDA Received Date: 04/12/2019
• 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