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

Catalog Number	129404050
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Tissue Damage (2104); Not Applicable (3189)
Date of Event	03/10/2018
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
Reason for revision: (b)(6) 2018: metallosis.
Additional Manufacturer Narrative
(b)(4).No device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may 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 STD+
• Common Device Name: KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7407334
• Report Number: 1818910-2018-56919
• Device Sequence Number: 1160932
• Product Code: NJL
• UDI-Device Identifier: 10603295021773
• UDI-Public: 10603295021773
• 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: 2005
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2018

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: No Information
• Device Catalogue Number: 129404050
• Device Lot Number: 1174627
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/10/2018
• Supplement Date Received by Manufacturer: 08/02/2018
• Initial Report FDA Received Date: 04/09/2018
• Supplement Report FDA Received Date: 08/29/2018
• 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: 83 YR