MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN CR HIGH FLEX XLPE SZ 7-8 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71453131
Medical Device Problem Code	Pitted (1460)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	04/27/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a tka, the patient presented with painful from initial surgery on (b)(6) 2018, with a lgn cr high flex xlpe sz 7-8 9mm, a revision surgery was performed on (b)(6) 2021, and was noted that the insert was pitted and the tibial baseplate was loose.The current health status of patient is unknown.
Event or Problem Description
It was reported that, after a tka, the patient presented with painful from initial surgery on (b)(6) 2018.A revision surgery was performed on (b)(6) 2021, and was noted that the lgn cr high flex xlpe sz 7-8 9mm insert was pitted and the tibial baseplate was loose.The femoral component was also extracted secondary to loosening.The current health status of patient is unknown.
Additional Manufacturer Narrative
A3, g3, h2,h3 and h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, x-ray revealed early lucency at the medial tibial tray and bone scan showed increased update throughout the knee; however, the requested surgical records and x-rays are not available.Without the requested documentation, the clinical root cause of the pain and loosening cannot be concluded.The patient impact beyond the revision cannot be determined.No further medical assessment can be rendered at this time.Should additional clinically relevant documentation become available the medical investigation 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.Factors and/or some potential probable causes that could contribute to the reported event have been identified as abnormal motion over time, bone degeneration, fit/sizing issue, lack of ingrowth, joint tightness, lifetime of device, and/or traumatic injury.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.We consider.

• Brand Name: LGN CR HIGH FLEX XLPE SZ 7-8 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11826841
• Report Number: 1020279-2021-04336
• Device Sequence Number: 3535261
• Product Code: JWH
• UDI-Device Identifier: 00885556033555
• UDI-Public: 00885556033555
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K071071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71453131
• Device Catalogue Number: 71453131
• Device Lot Number: 18GM01288
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/27/2021
• Supplement Date Received by Manufacturer: 08/09/2021
• Initial Report FDA Received Date: 05/14/2021
• Supplement Report FDA Received Date: 08/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention