MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LCS COMPLETE FEM CEM R STD; LCS COMPLETE : KNEE FEMORAL

Model Number	1294-01-040
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Headache (1880); Heartburn/Indigestion (1883); Itching Sensation (1943); Pain (1994); Rash (2033); Tinnitus (2103); No Code Available (3191)
Date of Event	11/01/2006
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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
Some of the problems i've had physically since this implant, and specifically since 2016 are: heart fluttering, heartburn, kidney/liver reading elevated, skin rashes and itching, headaches, continual coughing, nodual in throat, at times, pain in left knee, struggle to walk, achy joints, tinnitus, vision issues.Doi: (b)(6) 2006.Dor: revision schedule (a few months later).Right knee.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).Investigation summary: no device was received.Root cause undetermined.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 will be filed as appropriate.

• Brand Name: LCS COMPLETE FEM CEM R STD
• Common Device Name: LCS COMPLETE : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10072431
• Report Number: 1818910-2020-12289
• Device Sequence Number: 3753151
• Product Code: NJL
• UDI-Device Identifier: 10603295021551
• UDI-Public: 10603295021551
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2020

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 Expiration Date: 08/31/2011
• Device Model Number: 1294-01-040
• Device Catalogue Number: 129401040
• Device Lot Number: 2207429
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/11/2020
• Supplement Date Received by Manufacturer: 05/27/2020
• Initial Report FDA Received Date: 05/19/2020
• Supplement Report FDA Received Date: 06/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LCS COMP RP INSERT STD 12.5MM; LCS COMPLETE FEM CEM R STD; LCS COMPLETE M/B PAT CEM STD; MBT CEM TIBIAL TRAY SZ3; SMARTSET HV BONE CEMENT 40G
• Outcome Attributed to Adverse Event: Required Intervention