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

Catalog Number	129403040
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377)
Date of Event	05/23/2016
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 osteolysis.Medical records (b)(6) reviewed.Revision note (b)(6) revealed upon incision the tissue was all very soft and pliable, no pus or excess fluid.There was a large area of lysis whole of medical femoral condyle with hold of mcl.The surgeon indicates the correct decision was made to remove the distal femur as loosening was likely.Revision was completed without complication indicated by the surgeon.
Additional Manufacturer Narrative
Depuy considers the investigation closed at this time.Should the 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
This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.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
It was reported that the patient has experienced pain over her medial femoral condyle.
Additional Manufacturer Narrative
(b)(4).Investigation summary: conclusion and justification status: the complaint states the patient was revised to address osteolysis.Medical records reviewed.Revision note revealed upon incision the tissue was all very soft and pliable, no pus or excess fluid.There was a large area of lysis whole of medical femoral condyle with hold of mcl.The surgeon indicates the correct decision was made to remove the distal femur as loosening was likely.Revision was completed without complication indicated by the surgeon a review of complaint databases did not identify any anomalies.A review of manufacturing records was not required per (b)(4).A review of the x-rays did not identify any implant fracture or disassociation.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.The complaint shall be closed with an undetermined conclusion; entered into the complaints database and monitored through trend analysis.Post market surveillance is per sep 419.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: KNEE FEMORAL COMPONENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 6979038
• Report Number: 1818910-2017-27484
• Device Sequence Number: 444831
• Product Code: NJL
• UDI-Device Identifier: 10603295021698
• UDI-Public: 10603295021698
• 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 Implanted Year: 2008
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/26/2017

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: 129403040
• Device Lot Number: 2553003
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/26/2017
• Supplement Date Received by Manufacturer: 09/26/2017; 12/06/2017; 03/06/2018
• Initial Report FDA Received Date: 10/26/2017
• Supplement Report FDA Received Date: 10/26/2017; 12/11/2017; 03/07/2018
• 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: 70 YR