MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 LCS TEX PCR TIB PLAT STD+; KNEE TIBIAL TRAY

Catalog Number	118027000
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/04/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
The patient was revised to address pain and loosening of the tibial tray at unknown interface.Update 9/4/2017: determined that the tibial baseplate component is a press-fit, porous coated component, with regard to loosening interface (bone to implant).Complaint updated on: 10/2/2017.
Additional Manufacturer Narrative
No device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: LCS TEX PCR TIB PLAT STD+
• Common Device Name: KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 6907404
• Report Number: 1818910-2017-25779
• Device Sequence Number: 1111179
• Product Code: NJL
• UDI-Device Identifier: 10603295008309
• UDI-Public: 10603295008309
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2017

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: 118027000
• Device Lot Number: WNC-90
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/04/2017
• Supplement Date Received by Manufacturer: 10/23/2017
• Initial Report FDA Received Date: 10/02/2017
• Supplement Report FDA Received Date: 10/24/2017
• 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: Required Intervention
• Patient Age: 84 YR