MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 LCS COMP RP INSERT LG+ 10MM; LCS COMPLETE : KNEE TIBIAL INSERT

Catalog Number	129405710
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/30/2018
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) hospital (b)(6) 2018.Primary implanted by dr (b)(6) at (b)(6) hospital, primary implant date unknown and implant stickers unavailable.Revision for instability and pain bearing changed to 12.5mm and patella resurfaced.Male patient initials: (b)(6), dob: (b)(6).Impacted product: unknown jrn: lge+ 10mm lcs bearing lot number unknown = implant discarded.Related product: unknown jrn: lge+ rt lcs porous femoral component/ lot number unknown = still implanted.Unknown jrn: size 5 mbt cone cemented tibia/ lot number unknown = still implanted.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.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.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate. .

• Brand Name: LCS COMP RP INSERT LG+ 10MM
• 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: 7628988
• Report Number: 1818910-2018-62912
• Device Sequence Number: 1818285
• Product Code: NJL
• UDI-Device Identifier: 10603295022220
• UDI-Public: 10603295022220
• 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): 05/30/2018

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: 129405710
• Device Lot Number: A78JP4
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/30/2018
• Supplement Date Received by Manufacturer: 11/30/2018
• Initial Report FDA Received Date: 06/22/2018
• Supplement Report FDA Received Date: 12/01/2018
• 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: 67 YR