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

Catalog Number	129404040
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994); Not Applicable (3189)
Date of Event	05/16/2018
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
Revision femoral component due to femoral condole collapse; (b)(6) 2018.Patient underwent primary tkr on (b)(6) 2018 where an lcs was implanted - (dr (b)(6)).Patient has presented with a painful knee which appears to be in gross valgus.X rays indicate collapse of the lateral femoral condyle and the femoral component now sitting in gross valgus.Tibial component appears well fixed.The femoral component was removed and a stemmed modular lcs component with a lateral augment was stable and functioning well on the table.Female patient (b)(6).
Additional Manufacturer Narrative
(b)(4).Investigation summary no device associated with this report was received for examination, however review of the provided x-rays confirms the reported event.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 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: 7591273
• Report Number: 1818910-2018-61903
• Device Sequence Number: 11216086
• Product Code: NJL
• UDI-Device Identifier: 10603295021766
• UDI-Public: 10603295021766
• 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: 2018
• 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): 05/16/2018

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 129404040
• Device Lot Number: 8692240
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/16/2018
• Supplement Date Received by Manufacturer: 07/10/2018
• Initial Report FDA Received Date: 06/12/2018
• Supplement Report FDA Received Date: 07/20/2018
• 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: 75 YR