MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC 1818910 LCS COMPLETE FEM POR L LG; KNEE FEMORAL COMPONENT

Catalog Number	129404060
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/28/2017
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 stiff and painful knee.Revision was performed including soft tissue debridement and removal of osteophytes.Also, the primary procedure was performed 12 years ago and patient activity levels: activity decreased due to stiff knee.
Additional Manufacturer Narrative
(b)(4).Investigation summary: no device associated with this report was received for examination.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.
Additional Manufacturer Narrative
(b)(4).Investigation summary: no device associated with this report was received for examination.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 COMPLETE FEM POR L LG
• Common Device Name: KNEE FEMORAL COMPONENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 6982451
• Report Number: 1818910-2017-27588
• Device Sequence Number: 2144652
• Product Code: NJL
• UDI-Device Identifier: 10603295021780
• UDI-Public: 10603295021780
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2003
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/28/2017

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: 129404060
• Device Lot Number: 1120588
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/28/2017
• Supplement Date Received by Manufacturer: 04/27/2018; 10/01/2018
• Initial Report FDA Received Date: 10/26/2017
• Supplement Report FDA Received Date: 05/07/2018; 10/08/2018
• 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: 79 YR