MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LCS COMPLETE FEM POR R STD; LCS COMPLETE : KNEE FEMORAL

Catalog Number	129403040
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Pain (1994); Inadequate Osseointegration (2646); Not Applicable (3189)
Date of Event	08/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Revision knee replacement; (b)(6) hospital (b)(6) 2018.Primary implant date: (b)(6) 2017.Tibia stayed insitu.Femur removed due to areas of loosening or non-contact.Female patient id: (b)(6).
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).Investigation summary the reported event has been evaluated and will be monitored.Depuy synthes 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 R STD
• Common Device Name: LCS COMPLETE : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7832756
• Report Number: 1818910-2018-68153
• Device Sequence Number: 11278187
• Product Code: NJL
• UDI-Device Identifier: 10603295021698
• UDI-Public: 10603295021698
• 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: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/07/2018

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: Health Professional
• Device Catalogue Number: 129403040
• Device Lot Number: 8432702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2018
• Initial Date Received by Manufacturer: 08/07/2018
• Supplement Date Received by Manufacturer: 09/05/2018; 11/02/2018
• Initial Report FDA Received Date: 08/30/2018
• Supplement Report FDA Received Date: 09/14/2018; 11/02/2018
• 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: 82 YR