MAUDE Adverse Event Report: SMITH & NEPHEW, INC. G2 CONST INSRT SZ1-2 13MM; PRSTHSS, KNEE,PTLLFMRTBL,SM-CNSTRND,CMNTD,PLYMRMTLPLYMR

Catalog Number	OR71420962
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/29/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed because the insert had disengaged from the metal tibial baseplate.
Additional Manufacturer Narrative
The associated complaint devices were returned and evaluated.A lab analysis indicated burnishing, scratching, and deformation were visible on the distal surface of the insert, likely due to the insert riding on the tibial baseplate, which is consistent with the insert being reported as not locked in to the tibial baseplate.Damage to the anterior lock was visible.Signs of deformation were visible on the post.Based on the damage observed on the anterior and posterior region of the distal surface of the insert, the insert was not fully engaged during insertion.No material or manufacturing defects were observed during this investigation.A clinical analysis indicates that based on the lack of clinical/medical information, the root cause for the ¿insert disengagement¿ cannot be concluded, except that it might not have ever been fully engaged.Should any relevant information become available this complaint can be re-assessed.A review of complaint history on the listed part revealed no prior complaints for the listed part.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: G2 CONST INSRT SZ1-2 13MM
• Common Device Name: PRSTHSS, KNEE,PTLLFMRTBL,SM-CNSTRND,CMNTD,PLYMRMTLPLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7076660
• Report Number: 1020279-2017-01180
• Device Sequence Number: 19086263
• Product Code: JWH
• UDI-Device Identifier: 03596010210111
• UDI-Public: 03596010210111
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K962137
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2018

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: OR71420962
• Initial Date Received by Manufacturer: 11/29/2017
• Supplement Date Received by Manufacturer: 11/29/2017
• Initial Report FDA Received Date: 12/01/2017
• Supplement Report FDA Received Date: 04/11/2018
• 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