MAUDE Adverse Event Report: SMITH & NEPHEW, INC. G2 CONST INSRT SZ1-2 21MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED,

Catalog Number	71420968
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/29/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that revision surgery was reported due to femur had jumped the post of the tibial insert.Insert was removed.
Additional Manufacturer Narrative
The associated complaint device was not returned.The clinical/medical team concluded, no relevant supporting clinical information has been provided to assist with a clinical investigation, and the patient's current condition is unknown.Therefore based on insufficient information, a thorough clinical assessment cannot be performed at this time.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 listed part revealed no prior complaints for the listed batch.Without the actual device involved our investigation cannot proceed.If the device or new information is received in the future, the complaints can be re-opened.No further actions are being taken at this time.

• Brand Name: G2 CONST INSRT SZ1-2 21MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED,
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8640123
• Report Number: 1020279-2019-02036
• Device Sequence Number: 11324442
• Product Code: JWH
• UDI-Device Identifier: 03596010210142
• UDI-Public: 03596010210142
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K962137
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2019

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: 08/11/2025
• Device Catalogue Number: 71420968
• Device Lot Number: 15HM09653
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/29/2019
• Supplement Date Received by Manufacturer: 04/29/2019
• Initial Report FDA Received Date: 05/24/2019
• Supplement Report FDA Received Date: 10/22/2019
• 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