MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN PS HIGH FLEX XLPE SZ 1-2 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number 71453202

Device Problem Fitting Problem (2183)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/15/2021

Event Type  Injury  

Event Description

It was reported that during tka, the lgn ps high flex xlpe sz 1-2 11mm could not be seated to the baseplate.A 9mm smith and nephew insert back up device was available.No injury to patient or delay reported.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per complaint details, the 11mm insert could not be seated to the baseplate; therefore a backup (size 9mm) insert was used without delay or patient injury.It was communicated that the requested clinical documentation was not available for inclusion in the medical investigation.It remains unknown if the patient exhibited any post-op laxity with the 9mm insert, or if the surgeon was satisfied with the surgical outcome as the patient status was reportedly unknown.The clinical root cause could not be concluded.The patient impact beyond the reported intra-op connectivity issue could not be determined; however, no patient injury or surgical delay was reported.No further medical assessment could be rendered at this time.Should clinically relevant documentation/information and/or the product evaluation conclusion result in findings which are deemed clinically relevant, the clinical/medical task may be re-evaluated.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 did not reveal additional complaints for the listed batch.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include a fit/ sizing issue or poor insertion technique.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.

Manufacturer Narrative

H3, h6: the associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device does not confirm the stated failure mode.The returned insert has damage among the base, more than likely from attempted insertion.A dimensional inspection was attempted, but the device was too damaged from the attempted insertion to obtain accurate measurements.The clinical/medical investigation concluded that, per complaint details, the 11mm insert could not be seated to the baseplate; therefore a backup (size 9mm) insert was used without delay or patient injury.It was communicated that the requested clinical documentation was not available for inclusion in the medical investigation.It remains unknown if the patient exhibited any post-op laxity with the 9mm insert, or if the surgeon was satisfied with the surgical outcome as the patient status was reportedly unknown.The clinical root cause could not be concluded.The patient impact beyond the reported intra-op connectivity issue could not be determined; however, no patient injury or surgical delay was reported.No further medical assessment could be rendered at this time.Should clinically relevant documentation/information and/or the product evaluation conclusion result in findings which are deemed clinically relevant, the clinical/medical task may be re-evaluated.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 did not reveal additional complaints for the listed batch.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include a fit/ sizing issue or poor insertion technique.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.Additional information: d8/d9.

• Brand Name: LGN PS HIGH FLEX XLPE SZ 1-2 11MM
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12099747
• MDR Text Key: 259381727
• Report Number: 1020279-2021-05590
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00885556034316
• UDI-Public: 00885556034316
• Combination Product (y/n): N
• PMA/PMN Number: K071071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71453202
• Device Catalogue Number: 71453202
• Device Lot Number: 16BM10485A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2021
• Date Manufacturer Received: 10/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention