MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN PS HIGH FLEX XLPE SZ 3-4 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED,

Model Number	71453211
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Laxity (4526)
Date of Event	05/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal reference number (b)(4).
Event or Problem Description
*us legal* it was reported that, after a left tka performed on (b)(6) 2018, the plaintiff experienced a traumatic fall, which led to pain and instability.X-rays suggest that the liner is anterior to the tibial baseplate.A revision surgery was performed on (b)(6) 2019 to treat this adverse event.The liner was explanted.The patient outcome is unknown.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation but the images provided were reviewed, and the displacement was confirmed.The clinical/medical investigation concluded that, the root cause of the first revision was the anteriorly displaced insert secondary to a traumatic fall per documentation (b)(4).Based on the surgeon report of ¿more of a subacute problem¿ with radiological findings of cement anterior of the baseplate with heterotopic ossification and the intra-op finding of gross metallic staining of the surrounding soft tissues with severe wear of the femoral component (most likely from metal-on-metal articulation), along with the lab retrieval analysis conclusion that the insert wear/damage appears to match the shape/location of the rail of the baseplate locking mechanism and ¿indicates that the insert spent some time in-vivo not engaged correctly with the dovetail locking mechanism¿, it is unknown how long the patient actually ambulated with the disassociated component.The definitive root cause of the insert disassociation could not be concluded; however, the severity of the femoral and insert component wear and metal-stained tissues suggests a much longer duration that the 1 ½ weeks since the reported blunt-force-impact to the posterior knee (case-2020-00002563).The patient impact beyond the reported joint laxity, disassociation, pain, subsequent revisions, and noted metallic tissue staining during the 2nd revision could not be determined.A review of complaint history did not reveal additional complaints for the listed batch.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 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 include but are not limited to a traumatic injury.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.

• Brand Name: LGN PS HIGH FLEX XLPE SZ 3-4 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED,
• Manufacturer (Section D): SMITH & NEPHEW, INC.; brooks rd. 1450; memphis TN 38116
• MDR Report Key: 12388804
• Report Number: 1020279-2021-06612
• Device Sequence Number: 11656818
• Product Code: JWH
• UDI-Device Identifier: 00885556035252
• UDI-Public: 00885556035252
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2021

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: 71453211
• Device Catalogue Number: 71453211
• Device Lot Number: 17DT85494
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/12/2021
• Supplement Date Received by Manufacturer: 09/07/2021
• Initial Report FDA Received Date: 08/30/2021
• Supplement Report FDA Received Date: 09/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GII OVAL RESURFACING PAT 29MM/17KM02191; GNS II CMT TIB SIZE 4 LEFT/18BT99136; LEGION PS OXIN FEM SZ6 LT/18CM09556
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR