MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS HI FLEX ISRT SZ 5-6 11; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71421516
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Metal Related Pathology (4530)
Date of Event	01/05/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after tka, post on genesis ii ps high flex insert size 5-6 11 broke.A revision surgery was performed, post was found in the notch and metallosis was noticed in the knee.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 confirmed the stated failure mode.The device was broken, rendering the device inoperative.The lab analysis concluded that the as received component was visually inspected for signs of damage.The tibial insert showed signs of wear related damage to the articulating surface.The post was fractured near the base of the post.Signs of deformation were observed on the anterior, posterior, medial, and lateral regions of the insert post.No material or manufacturing defects were observed during this investigation.The clinical/medical evaluation concluded that although the provided intra-op images appeared to show tissue-staining which may be seen in the presence of metallosis, without the requested medical documentation, the source could not be definitively identified, and a mal-performance of the device could not be established.Therefore, based on the limited information provided, the clinical root cause of the reported insert post breakage with metallosis could not be confirmed nor concluded.The patient impact beyond the reported post breakage, ¿metallosis¿ and revision could not be determined.No further medical assessment can be rendered at this time.Should clinical documentation and/or relevant analysis findings become available in the future, 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 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.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 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 HI FLEX ISRT SZ 5-6 11
• 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: 11229827
• Report Number: 1020279-2021-00591
• Device Sequence Number: 3571029
• Product Code: JWH
• UDI-Device Identifier: 03596010492333
• UDI-Public: 03596010492333
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K032295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• 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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/26/2019
• Device Model Number: 71421516
• Device Catalogue Number: 71421516
• Device Lot Number: 09HM17922
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2021
• Initial Date Received by Manufacturer: 01/05/2021
• Supplement Date Received by Manufacturer: 08/12/2021
• Initial Report FDA Received Date: 01/26/2021
• 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; Required Intervention