MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS HI FLEX ISRT SZ 7-8 13; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71421524
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/10/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, following a left tka surgery performed 15 years ago, the patient experienced an incident and noticed a "difference in the knee".X-rays revealed potential breakage of the ps articular insert.A revision surgery was performed on (b)(6) 2023 to treat this adverse event.During this procedure, a synovectomy and debridement of the joint was performed.The broken hardware was confirmed and extracted, and cement debris from the postero-lateral compartment was also removed.Patient's current health status is unknown.
Additional Manufacturer Narrative
B5, h3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation stated that, based on the information provided, it is unknown if the reported ¿incident¿ when the patient ¿felt a difference in his left knee¿ involved a traumatic event to the left total knee arthroplasty after approximately 15 years in vivo; however, the findings of the broken post tip along with noted cement debris would correlate with an injury, but this cannot be definitively concluded.The patient impact included the fractured post with cement debris in the knee joint and the subsequent insert revision/synovectomy/debridement with removal of post tip and debris.Further patient impact cannot be determined, although a transient recovery phase would be anticipated.No further medical assessment can be rendered at this time.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the instructions for use documents for knee systems revealed that the implant can break or become damaged as a result of strenuous activity or trauma.The patient should be warned that the device does not replace normal healthy bone.This has been identified as a warning and precaution.A review of the risk management file 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 specifications at the time of manufacture.Factors that could contribute to the reported event include abnormal loading of limb, excessive forces and/or traumatic injury.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.We consider this investigation closed.
Event or Problem Description
It was reported that, following a left tka surgery performed 15 years ago, the patient experienced an incident and noticed a "difference in the knee".X-rays revealed potential breakage of the ps articular insert.A revision surgery was performed on (b)(6) 2023 to treat this adverse event.During this procedure, a synovectomy and debridement of the joint was performed.The broken hardware was confirmed and extracted, and cement debris from the postero-lateral compartment was also removed.Patient's current health status is good.

• Brand Name: GII PS HI FLEX ISRT SZ 7-8 13
• 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: 17347286
• Report Number: 1020279-2023-01454
• Device Sequence Number: 6091467
• Product Code: JWH
• UDI-Device Identifier: 03596010492999
• UDI-Public: 03596010492999
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K032295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2023

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: 01/24/2019
• Device Model Number: 71421524
• Device Catalogue Number: 71421524
• Device Lot Number: 09AM19739
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2023
• Supplement Date Received by Manufacturer: 08/23/2023
• Initial Report FDA Received Date: 07/18/2023
• Supplement Report FDA Received Date: 08/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2009
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown
• Patient Weight: 128 KG