MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN PS HIGH FLEX XLPE SZ 3-4 15MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71453214
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	09/05/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed.After approx.6 weeks insitu.Insert dislocated from locking mechanism post fall.Surgeon believes on inspection that it may have never been locked in at the time of primary surgery.Signs of femoral implant condylar wear associated with articulation with the tibial base plate.Kindly investigate the explanted poly.
Additional Manufacturer Narrative
The associated complaint devices were returned and evaluated.A lab analysis was performed and wear is seen on the articulating and non-articulating surfaces of the insert.The non-articulating surface has scratches and deformation.The locking detail is deformed.There were no observations of material or manufacturing deviations in the course of this investigation.A clinical evaluation was conducted and it has been communicated via email that no relevant supporting clinical information will be provided, and there is no report of the patient's current condition.However, the explanted device was returned for analysis, which indicates that wear is seen on both the articulating and non-articulating surfaces of the insert.Additionally, the locking detail was deformed, which is consistent with the surgeon's statement that he "believes on inspection that it may have never been locked in at the time of primary surgery." no further medical assessment is warranted based on the information provided.A review of complaint history on the listed parts revealed no prior complaints for the listed batches with the same failure mode.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: LGN PS HIGH FLEX XLPE SZ 3-4 15MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7924166
• Report Number: 1020279-2018-01987
• Device Sequence Number: 1484719
• Product Code: JWH
• UDI-Device Identifier: 00885556035108
• UDI-Public: 00885556035108
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K071071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2019

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 Expiration Date: 11/02/2017
• Device Catalogue Number: 71453214
• Device Lot Number: 17LM01253
• Initial Date Received by Manufacturer: 09/05/2018
• Supplement Date Received by Manufacturer: 09/05/2018
• Initial Report FDA Received Date: 10/01/2018
• Supplement Report FDA Received Date: 02/10/2019
• 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: 71421165/LGN OX CONSTRAINED FEM 5 LT/17LM02050; 71421165/LGN OX CONSTRAINED FEM 5 LT/17LM02050
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention