MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN PS HIGH FLEX XLPE SZ 1-2 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71453203
Medical Device Problem Codes	Positioning Failure (1158); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that, during total knee arthroplasty, a legion polyethylene insert size 1-2 13mm failed to be positioned.Upon attempting to insert the implant, a little flaky on the insert was caused.No flakes fell into the patient.Surgery was resumed, after a non-significant delay, with a smith & nephew back-up device.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation.The pictures provided were reviewed and could not confirm the positioning failure or the alleged produced flakes.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 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 that could contribute to the reported event include size selected or poor insertion technique.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.
Additional Manufacturer Narrative
The associated device was returned and evaluated.The visual inspection revealed scratches on the flat portion of the device.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 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.According with inspection drawing, it includes the verification of part configuration per production order and print.Also, material specification shall control the quality and manufacture of 7.5 mrad cross-linked ultra-high-molecular-weight polyethylene (uhmwpe) bar stock.A review made by the quality engineering team revealed that visual inspection revealed considerable damage to the locking detail of the part from attempted use.Also there is damage at the dovetail side that is consistent with the insert not being positioned properly.Based on the evidence provided, the unsatisfactory experience could be confirmed.It is unknown if this was the cause of the stated failure mode, however there is no evidence that this damage occurred prior to use.A dimensional inspection of the returned device could not confirm or explain the stated failure mode.The device has signs of damage from attempted use.A dimensional inspection was attempted; the damage/deformation at several features of the device would not allow for accurate measurement.All applicable, critical features that could be measured were within specification.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.With the results of this investigation the root cause of this event could not be determined.Factors that could contribute to the reported event include insertion technique, mishandling or user/procedural variance.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.

• Brand Name: LGN PS HIGH FLEX XLPE SZ 1-2 13MM
• 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: 15393498
• Report Number: 1020279-2022-04041
• Device Sequence Number: 5098068
• Product Code: JWH
• UDI-Device Identifier: 00885556034804
• UDI-Public: 00885556034804
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K071071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71453203
• Device Catalogue Number: 71453203
• Device Lot Number: 22DM06118
• 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: 08/22/2022
• Supplement Date Received by Manufacturer: 10/14/2022; 02/10/2023
• Initial Report FDA Received Date: 09/09/2022
• Supplement Report FDA Received Date: 10/18/2022; 02/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2022
• 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
• Patient Sex: Unknown