MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS INSERT SZ 3-4 13MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Model Number	71420820
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/05/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after 13 years from the primary procedure, a revision surgery to replaced a poly was performed due to a post-broke in the patient.The gii ps insert sz 3-4 13mm was explanted.Patient outcome is unknown.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation but the pictures were reviewed, and the failure mode was confirmed.The clinical/medical investigation concluded that, per complaint details, approximately 13 years post implantation, a poly revision was performed due to a ¿post broke in the patient¿.It was communicated that the requested documentation was not available.Reportedly, the root cause was the broken insert post; however, the cause of the break could not be fully assessed and/or concluded based on the limited information provided.The patient impact beyond the reported event and subsequent revision could not be determined.No further medical assessment can be rendered at this time.Should clinically relevant documentation/information become available, the clinical/medical task may be re-evaluated.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history did not reveal additional complaints for the listed batch.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include but not limited to traumatic injury or surgical technique.Based on this investigation, the need for corrective action is not indicated.Should the device or 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.

• Brand Name: GII PS INSERT SZ 3-4 13MM
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11593552
• Report Number: 1020279-2021-02572
• Device Sequence Number: 3606086
• Product Code: JWH
• UDI-Device Identifier: 03596010209597
• UDI-Public: 03596010209597
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2021

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 Expiration Date: 10/25/2018
• Device Model Number: 71420820
• Device Catalogue Number: 71420820
• Device Lot Number: 08KM20294
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/05/2021
• Supplement Date Received by Manufacturer: 08/12/2021
• Initial Report FDA Received Date: 03/30/2021
• Supplement Report FDA Received Date: 08/15/2021
• 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; Other; Required Intervention