MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN PS HIGH FLEX XLPE SZ 7-8 11MM; PROST, KNEE, PATFEMTIB, SEMI-CNSTRND, CMNTD, POLY/MET/POLY

Model Number	71453232
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/15/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a tka surgery, a revision surgery had to be performed.A legion ps high flex xlpe size 7-8 11mm poly was exchanged.The poly explanted appears to have a warped post.Current patient health status remains unknown.
Additional Manufacturer Narrative
Internal reference number: (b)(4).
Additional Manufacturer Narrative
H3, h6: the associated device was returned and evaluated.The contribution of the device to the reported event could not be corroborated.A visual inspection of the returned device confirmed the stated failure mode.The post of the device is warped, rendering the device inoperative.The face and base of the device is severely scratched.The device shows signs of extensive use.The clinical/medical evaluation concluded that per case details, a revision was performed after a tka.The date of the primary surgery was unspecified.Reportedly, ¿the poly explanted appears to have a warped post and the patient¿s current health status is unknown.It has been reported that no additional requested information was provided.Without clinically relevant information for evaluation, the root cause of the reported warped post and revision cannot be definitively concluded.Further patient impact beyond the reported event could not be assessed.No further medical assessment could be rendered at this time.A review of complaint history did not reveal similar events for the listed device.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.Potential probable causes could be but are not limited to wear and/or deformation from surgical procedure, patient anatomy, or abnormal loading of limb.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.

• Brand Name: LGN PS HIGH FLEX XLPE SZ 7-8 11MM
• Common Device Name: PROST, KNEE, PATFEMTIB, SEMI-CNSTRND, CMNTD, POLY/MET/POLY
• 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: 12763419
• Report Number: 1020279-2021-07879
• Device Sequence Number: 11622915
• Product Code: JWH
• UDI-Device Identifier: 00885556035153
• UDI-Public: 00885556035153
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K071071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 71453232
• Device Catalogue Number: 71453232
• Device Lot Number: 17BT82027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2021
• Supplement Date Received by Manufacturer: 12/29/2021
• Initial Report FDA Received Date: 11/07/2021
• Supplement Report FDA Received Date: 12/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2017
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown