MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN PS HIGH FLEX XLPE SZ 7-8 11MM; PROSTH, KNEE, PATELLOFE, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Model Number	71453232
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference number: (b)(4).
Event or Problem Description
It was reported that, after a tka surgery had been performed, the patient had a fall causing the post to fracture.This adverse event was addressed by a revision surgery on (b)(6) 2022 to exchange the lgn ps high flex xlpe sz 7-8 11mm.Current health status of patient is unknown.
Additional Manufacturer Narrative
H10: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per complaint details, an insert revision was performed after an unknown length of time in-situ¿ due to the surgeon ¿suspected that the post was fractured¿ after the ¿patient had a fall¿.The requested medical documentation has not been received as of the date of this medical investigation.The current health status of patient remains unknown.Without the requested clinical documentation, the root cause of the reported event could not be further assessed.The patient impact beyond the reported fall and subsequent insert revision could not be determined.No further medical assessment could be rendered at this time.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 revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the instructions for use documents for knee systems revealed that fracture of implant components has been identified as a possible adverse effect that may occur as a result of trauma or strenuous activity.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 product specifications at the time of manufacture.Factors and/or potential causes that could contribute to the reported event include excessive forces applied to implant and traumatic injury.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, 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.We consider this investigation closed.Internal complaint reference number: (b)(4).
Additional Manufacturer Narrative
H3, h6: the associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device was found to be fractured along the post, rendering the device inoperative.The device's fractured post was returned was returned as well.A review of complaint history revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.The clinical/medical evaluation concluded that per complaint details, an insert revision was performed after an unknown length of time in-situ¿ due to the surgeon ¿suspected that the post was fractured¿ after the ¿patient had a fall¿.The requested medical documentation has not been received as of the date of this medical investigation.The current health status of patient remains unknown.Without the requested clinical documentation, the root cause of the reported event could not be further assessed.The patient impact beyond the reported fall and subsequent insert revision could not be determined.No further medical assessment could be rendered at this time.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 document revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.The contribution of the device to the reported incident could be corroborated as the device was broken and required a revision surgery to treat this event.Factors that could contribute to the reported event include traumatic injury, size selected, surgical technique or postoperative care.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 future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: LGN PS HIGH FLEX XLPE SZ 7-8 11MM
• Common Device Name: PROSTH, KNEE, PATELLOFE, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
• 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: 14438557
• Report Number: 1020279-2022-02433
• Device Sequence Number: 5733033
• Product Code: JWH
• UDI-Device Identifier: 00885556035153
• UDI-Public: 00885556035153
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K071071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/10/2022

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: Lay User/Patient
• Device Expiration Date: 08/10/2018
• Device Model Number: 71453232
• Device Catalogue Number: 71453232
• Device Lot Number: 08HM07924
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2022
• Supplement Date Received by Manufacturer: 06/17/2022; 10/06/2022
• Initial Report FDA Received Date: 05/19/2022
• Supplement Report FDA Received Date: 06/20/2022; 10/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2008
• 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