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

Catalog Number 129429060

Device Problem Loss of or Failure to Bond (1068)

Patient Problems No Consequences Or Impact To Patient (2199); Not Applicable (3189)

Event Date 04/21/2018

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Revision total knee replacement, dr.(b)(6) (b)(6) 2018.Revision of revision lcs tkr due to femoral loosening, tibia remained institu.Patient initials: (b)(6), male (b)(6).Unknown jrn: lcs comp rp large 12.5mm revision.Unknown jrn: large femur left revision.Unknown: jrn: 115 x 20 mm uncemented tibial stem.

Manufacturer Narrative

(b)(4).Investigation summary no device associated with this report was received for examination.Depuy synthes considers the investigation closed.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 REV FEM CEM L LG
• Type of Device: KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-XXXX ; 6103142063
• MDR Report Key: 7529658
• MDR Text Key: 108759273
• Report Number: 1818910-2018-60085
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/21/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: 129429060
• Device Lot Number: 176213
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/21/2018
• Initial Date FDA Received: 05/21/2018
• Supplement Dates Manufacturer Received: 05/20/2018; 11/15/2018
• Supplement Dates FDA Received: 05/30/2018; 11/26/2018
• Date Device Manufactured: 02/13/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR