MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 LCS COMP RP INSERT STD+ 12.5MM; LCS COMPLETE : KNEE TIBIAL INSERT

Catalog Number	129405512
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), (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: km, aged (b)(6) years, dob: (b)(6), weight: (b)(6) kg, height: 155 cm.Doi: 6 weeks ago; dor: (b)(6) 2018; unknown knee.
Additional Manufacturer Narrative
(b)(4).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 COMP RP INSERT STD+ 12.5MM
• Common Device Name: LCS COMPLETE : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7511098
• Report Number: 1818910-2018-59523
• Device Sequence Number: 1694915
• Product Code: NJL
• UDI-Device Identifier: 10603295022091
• UDI-Public: 10603295022091
• 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: 129405512
• 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