MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 1818910 LCS COMPLETE FEM CEM L LG; LCS COMPLETE : KNEE FEMORAL

Catalog Number	129402060
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/26/2018
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
Revision total knee replacement; dr (b)(6); (b)(6) on (b)(6) 2018 - patient underwent primary tkr on (b)(6) 2016 where an lcs component was implanted (dr (b)(6), (b)(6) hospital).Patient was doing well until approximately 12 moths post surgery when he describes "something happened".Following this incident his knee has become progressively more painful.X rays show the femoral component has come loose and is sitting in a flexed position.There also appears to be lucent lines under the tibial component.A decision was made to revise the knee - dr (b)(6), (b)(6) on (b)(6) 2018.On opening the knee the femoral component was loose.There appeared to be debonding at the cement implant interface.The surgeon commented that this may have been a result of his cement technique which he has now modified.The tibial component was relatively well fixed.All components were removed and a pfc tc3 rp with sleeves on both the femur and tibia implanted.Male patient initials (b)(6).
Additional Manufacturer Narrative
Additional narrative: product complaint # = > (b)(4).Investigation summary = > 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.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 COMPLETE FEM CEM L LG
• Common Device Name: LCS COMPLETE : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7707494
• Report Number: 1818910-2018-64919
• Device Sequence Number: 14088723
• Product Code: NJL
• UDI-Device Identifier: 10603295021643
• UDI-Public: 10603295021643
• 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: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2018

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: 129402060
• Device Lot Number: 8092488
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/26/2018
• Supplement Date Received by Manufacturer: 09/07/2018
• Initial Report FDA Received Date: 07/20/2018
• Supplement Report FDA Received Date: 09/10/2018
• 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: 59 YR