MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 LCS COMPLETE M/B PAT POR STD+; LCS COMPLETE : KNEE PATELLA

Catalog Number	129409650
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Not Applicable (3189)
Date of Event	04/18/2018
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 knee; dr (b)(6), (b)(6) hospital (b)(6) 2018.Tibial insert and patella insert changed for an infected knee with wound breakdown.Patient had original knee replacement 6 weeks ago.Actual operation date unknown, no x-ray's or patient notes available.Female patient initials: (b)(6), aged (b)(6) years, dob:(b)(6), weight: (b)(6), height: (b)(6) doi: 6 weeks ago; dor: (b)(6) 2018 unknown knee.
Additional Manufacturer Narrative
(b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may 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 M/B PAT POR STD+
• Common Device Name: LCS COMPLETE : KNEE PATELLA
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7511069
• Report Number: 1818910-2018-59524
• Device Sequence Number: 1385206
• Product Code: NJL
• UDI-Device Identifier: 10603295022657
• UDI-Public: 10603295022657
• 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): 04/18/2018

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: 129409650
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/18/2018
• Supplement Date Received by Manufacturer: 11/27/2018
• Initial Report FDA Received Date: 05/14/2018
• Supplement Report FDA Received Date: 11/28/2018
• 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: 65 YR
• Patient Weight: 110