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

Model Number	1294-29-040
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/19/2019
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
Hcp reported to (b)(6): "relative movement of the femoral shield.The epiphyseal zone is loosened and the plug cone to the metaphyseal sleeve shows distinct corrosion marks (fretting).Loosening of the femoral component after knee-tep-change in (b)(6) 2018.Knee-tep lcs revision on (b)(6) 2019 - partially coupled, stalk guided, partially cemented.".
Additional Manufacturer Narrative
Product complaint # (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
Height: 157.Operated side: left.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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.Corrected: h3 and h6 (device code and closure codes).Product complaint # : (b)(4).Investigation summary : following review of the information received, it was concluded that it could not be determined whether a potential product issue was present.The complaint shall be entered onto the complaints database and monitored through trend analysis.Should further information be received, then the complaint shall be reviewed and further investigation completed as required.Device history lot : null.Device history batch : null.Device history review : null.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 COMPLETE REV FEM CEM L STD
• Common Device Name: LCS REVISION : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9221164
• Report Number: 1818910-2019-111253
• Device Sequence Number: 11364965
• Product Code: JWH
• UDI-Device Identifier: 10603295025528
• UDI-Public: 10603295025528
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/23/2019

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1294-29-040
• Device Catalogue Number: 129429040
• Device Lot Number: HN6808
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 11/25/2019
• Initial Date Received by Manufacturer: 09/23/2019
• Supplement Date Received by Manufacturer: 11/11/2019; 11/25/2019; 01/16/2020
• Initial Report FDA Received Date: 10/22/2019
• Supplement Report FDA Received Date: 12/06/2019; 12/10/2019; 01/22/2020
• 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: COMPETITOR BONE CEMENT; LCS COMP VVC INS STD 10MM; MBT REVISION CEM TIB TRAY SZ 2; UNIVERSAL STEM 75X12MM FLUTED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Weight: 58