MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN PS HIGH FLEX XLPE SZ 1-2 9MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	71453201
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/08/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to dislocation.The insert was exchanged.
Additional Manufacturer Narrative
The associated device,used in treatment, was returned and evaluated.The lab analysis examined the device visually.Abrasion and deformation were visible on the articulating surface.These features observed on the device have been reported as being created by third-body particulate in the joint space.Cement and bone particulate are known to be produced during a tka, even under carefully controlled conditions.Abrasion, deformation, and scratches were also observed on the non-articulating inferior surface of the insert.Portions of the locking mechanism were deformed.Some deformation and wear was visible on the post of the insert.No material or manufacturing deviations were observed in this investigation.The medical investigation concluded that this complaint reports a revision of a knee secondary to dislocation.No clinical/medical documents were provided for this investigation.The product analysis did not find any material or manufacturing deviations.Abrasions, deformations and scratches were observed and even under the best conditions third-body particulates are known to be produced.The impact to the patient beyond the surgery and recovery cannot be determined.Based on the available information, the root cause of the ¿dislocation¿cannot be concluded at this time.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.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.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.

• Brand Name: LGN PS HIGH FLEX XLPE SZ 1-2 9MM
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9255858
• Report Number: 1020279-2019-03820
• Device Sequence Number: 3763942
• Product Code: JWH
• UDI-Device Identifier: 00885556033784
• UDI-Public: 00885556033784
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K071071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2020

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 71453201
• Device Lot Number: 15KM6150
• Initial Date Received by Manufacturer: 10/08/2019
• Supplement Date Received by Manufacturer: 01/10/2020
• Initial Report FDA Received Date: 10/30/2019
• Supplement Report FDA Received Date: 01/14/2020
• 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