MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII CR DEEP FLEX ISRT S1-2 11M; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71421532
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/26/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a tka had been performed, the patient experienced an unspecified adverse event.A revision surgery had to be performed to exchange the s1-2 11m genesis ii cr deep flexion insert.The patient outcome is unknown.
Additional Manufacturer Narrative
The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device shows the insert is severely damaged.Cracks are observed on the inferior surface of the device.The bottom part has few pieces fragmented.The broken pieces have been returned.The clinical/medical evaluation concluded that it was reported that a revision tka was performed to swap the poly insert.The requested x-rays and surgical reports have not been provided to date.Without adequate documentation/information, the root cause of the reported events cannot be fully evaluated.Therefore, the patient impact beyond the reported revision cannot be determined.No further medical assessment is warranted at this time.Should clinically relevant documentation/ information become available, the clinical/medical task may be re-evaluated.The lab evaluation concluded that the components were inspected visually to determine the cause of the reported incident.No destructive analysis was conducted during this investigation.Damage is present on both medial and lateral side of the articulating surface of the insert.Pieces were fractured off of the insert.There were no observations of material or manufacturing deviations in the course of this investigation.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have 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 and potential harm was previously identified.Factors and/or some potential probable causes that could contribute to the reported event have been identified as overuse or excessive pressure on the joint, injury, infection and/or patient condition.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: GII CR DEEP FLEX ISRT S1-2 11M
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10280595
• Report Number: 1020279-2020-03248
• Device Sequence Number: 2613371
• Product Code: JWH
• UDI-Device Identifier: 03596010520357
• UDI-Public: 03596010520357
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K041825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2021

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: 71421532
• Device Catalogue Number: 71453102
• Device Lot Number: 10JM04750
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2020
• Initial Date Received by Manufacturer: 06/26/2020
• Supplement Date Received by Manufacturer: 08/09/2021
• Initial Report FDA Received Date: 07/15/2020
• Supplement Report FDA Received Date: 08/09/2021
• 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