MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 LCS COM RPSFLEX FEM CEM R STD+; LCS COMPLETE : KNEE FEMORAL

Catalog Number	129411050
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).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 and loosening of the femoral component at the cement to implant interface.Cement manufacturer is unknown.Doi: (b)(6) 2008; dor: (b)(6) 2017; right knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Device history lot: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: LCS COM RPSFLEX FEM CEM R STD+
• Common Device Name: LCS COMPLETE : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 7167247
• Report Number: 1818910-2018-50280
• Device Sequence Number: 1822990
• Product Code: NJL
• UDI-Device Identifier: 10603295022862
• UDI-Public: 10603295022862
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2017

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: 129411050
• Device Lot Number: 2572890
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/06/2017
• Supplement Date Received by Manufacturer: 04/05/2018
• Initial Report FDA Received Date: 01/05/2018
• Supplement Report FDA Received Date: 04/06/2018
• 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: 68 YR
• Patient Weight: 123