MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 LCS COM POST AUG 5MM LG; LCS COMPLETE : KNEE FEMORAL ACCESSORY

Catalog Number	129427060
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Not Applicable (3189)
Date of Event	04/21/2018
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) 2018.Revision of revision lcs tkr due to femoral loosening, tibia remained institu.Patient initials: (b)(6), male aged (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.
Additional 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 COM POST AUG 5MM LG
• Common Device Name: LCS COMPLETE : KNEE FEMORAL ACCESSORY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7613072
• Report Number: 1818910-2018-62500
• Device Sequence Number: 1556264
• Product Code: NJL
• UDI-Device Identifier: 10603295025382
• UDI-Public: 10603295025382
• 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 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): 05/20/2018

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: 129427060
• Device Lot Number: 135072
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/20/2018
• Supplement Date Received by Manufacturer: 11/15/2018
• Initial Report FDA Received Date: 06/19/2018
• Supplement Report FDA Received Date: 11/26/2018
• 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: 72 YR