MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 LCS COMPLETE FEM POR R MED; LCS COMPLETE : KNEE FEMORAL

Catalog Number	129403030
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	Pain (1994); Inadequate Osseointegration (2646); Not Applicable (3189)
Date of Event	03/26/2018
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
The patient was revised to address pain, poor function and femoral loosening at the bone to implant interface.It was also reported that when they opened the patient and started the stability of the femoral component it was found to be not well fixed.The femur was removed and stemmed sigma ps femur with stems was cemented.A sigma rp insert was inserted and the lcs patella was retained.Surgeon was happy with result.The femur looked like a porous lcs femur.Doi: unknown.Dor: (b)(6) 2018 right knee.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: 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 R MED
• Common Device Name: LCS COMPLETE : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7446579
• Report Number: 1818910-2018-57937
• Device Sequence Number: 11204767
• Product Code: NJL
• UDI-Device Identifier: 10603295021681
• UDI-Public: 10603295021681
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2018

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: 129403030
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/26/2018
• Supplement Date Received by Manufacturer: 11/20/2018
• Initial Report FDA Received Date: 04/20/2018
• Supplement Report FDA Received Date: 11/21/2018
• 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: 53 YR