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 Code	Failure of Implant (1924)
Date of Event	01/26/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: case (b)(4).
Event or Problem Description
It was reported that, after total knee arthroplasty was performed on 2007, the patient experienced breakage of the implanted genesis ii posterior stabilized high flexion insert size 5-6 11mm.This happened on (b)(6) 2022 when the patient was crossing legs and a "pop" sound was heard.This adverse event was treated with a revision surgery on (b)(6) 2022.Patient's current health status is unknown.
Additional Manufacturer Narrative
H10: the associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The implanted device is damaged and broken and has discoloration from use.According to clinical/medical investigation a revision was performed approximately 15 years post implantation due to ¿breakage¿ of the insert ¿when the patient was crossing legs and a "pop" sound was heard¿.Responses to the clinical information requests have not been provided as of the date of this medical investigation.The explant photo appears to support the complaint with a fractured post.The patient's current health status is unknown.Without the requested documentation, the root cause of the reported event could not be definitively concluded.Patient impact beyond the reported ¿pop¿ during the leg-crossing event and subsequent revision with findings of a fractured post of the patellar component could not be determined.No further medical assessment is warranted at this time.A review of complaint history of the previous 12 months revealed similar events for the listed device, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file and instructions for use document revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.The probable causes for this reported event could be but not limited to patients anatomy, traumatic injury, or abnormal motion/loading of the limb.The contribution of the device to the reported incident could be corroborated as there is visible damage to the device.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.Internal reference number: (b)(4).

• 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
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 13545748
• Report Number: 1020279-2022-00754
• Device Sequence Number: 2124205
• 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 Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2022

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 Model Number: 71421516
• Device Catalogue Number: 71421516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2022
• Supplement Date Received by Manufacturer: 03/17/2022
• Initial Report FDA Received Date: 02/16/2022
• Supplement Report FDA Received Date: 03/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown