MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS INSERT SZ 5-6 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71420830
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/27/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a tka had been performed, a revision surgery was performed to exchange the genesis ii ps insert size 5-6 9mm due to a broken post.The outcome of the patient is unknown.
Additional Manufacturer Narrative
The device, intended for use in treatment/used in treatment, was not received for evaluation and the reported event could not be confirmed.The shipping information was provided and all efforts were made to locate the device but we have no evidence that it was ever received by the complaint investigation team for evaluation.If the device is received in the future, the complaint will be reopened to evaluate.Attached photos confirmed the stated failure mode.The post of the device device is broken off, rendering the device inoperative.The device shows signs of extensive use.The clinical/medical evaluation concluded that this case reports that approximately 10 years after a tka, a revision/liner exchange was performed due to a broken post.Per email communication, there is no consent granted to provide x-rays or surgical reports, and no further information has been provided.Therefore, the patient impact beyond the revision cannot be determined.No further clinical assessment is warranted at this time.Should clinically relevant documentation become available, the clinical/medical task may be re-evaluated.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 have no 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.Some potential probable causes for this event could include but not limited to traumatic injury, surgical technique or implant failure.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved or product information, our investigation could not proceed.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 5-6 9MM
• 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: 10859797
• Report Number: 1020279-2020-06554
• Device Sequence Number: 16794630
• Product Code: JWH
• UDI-Device Identifier: 03596010209641
• UDI-Public: 03596010209641
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/29/2018
• Device Model Number: 71420830
• Device Catalogue Number: 71420830
• Device Lot Number: 08GT22609
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/27/2020
• Supplement Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 11/18/2020
• Supplement Report FDA Received Date: 09/10/2021
• 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