MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN PS HIGH FLEX XLPE SZ 5-6 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71453222
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	10/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a tka surgery, a lgn ps high flex xlpe sz 5-6 11mm cam broke.A revision surgery was performed in order to exchanged the broken insert.It is unknown the current health status of the patient.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Additional Manufacturer Narrative
Additional information: b5, h6.
Event or Problem Description
It was reported that, during a revision surgery (unspecified cause), a lgn ps high flex xlpe sz 5-6 11mm cam broke, inside the patient, while trying to be inserted.It is unknown how the pieces were retrieved.The revision surgery was completed with a s+n back up device and without any delay.It is unknown current health status of the patient.
Additional Manufacturer Narrative
Section h10: the device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, per complaint details, a revision was performed approximately 8 years post implantation due to the insert ¿cam broke¿.It was communicated that the requested documentation was not available, and the current patient status is unknown.Without the supporting clinical documentation, no clinical factors could be concluded to have contributed to the event.Patient impact beyond the reported post breakage and revision procedure could not be determined.No further medical assessment can be rendered at this time.Device batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.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 instructions for use documents for knee systems revealed in warnings and precautions 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.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 drawing print, the final inspection includes the verification of part configuration per print.Also, material specification document shall control the quality and manufacture of the material used for implant manufacture.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 traumatic injury or size selected.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.Internal complaint reference number: case-2022-00131469-1.
Event or Problem Description
It was reported that, after a tka surgery performed in 2014, a lgn ps high flex xlpe sz 5-6 11mm cam broke.A revision surgery was performed on (b)(6) 2022, in order to exchanged the broken insert.It is unknown the current health status of the patient.
Additional Manufacturer Narrative
Additional information: d6b b5.

• Brand Name: LGN PS HIGH FLEX XLPE SZ 5-6 11MM
• 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: 15974817
• Report Number: 1020279-2022-04957
• Device Sequence Number: 6960295
• Product Code: JWH
• UDI-Device Identifier: 00885556035351
• UDI-Public: 00885556035351
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K071071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/06/2023

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 Model Number: 71453222
• Device Catalogue Number: 71453222
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2022
• Supplement Date Received by Manufacturer: 12/13/2022; 01/10/2023; 02/02/2023
• Initial Report FDA Received Date: 12/14/2022
• Supplement Report FDA Received Date: 12/21/2022; 01/12/2023; 02/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown