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

Model Number	1294-04-040
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will 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.
Event or Problem Description
It was reported that on (b)(6) 2016, the patient underwent an unknown surgery.After surgery, infection occurred.Since the infection has loosened both the femur and tibia, the surgeon intends to perform a revision in 2 stages.On (b)(6) 2022, the 1st revision surgery was performed successfully.The implants used in the initial surgery were removed, and a mold was newly used for the treatment.On (b)(6) 2022, the 2nd revision surgery will be performed with attune implants.Doi: (b)(6) 2016.Dor: (b)(6) 2022.Unknown side.

• Brand Name: LCS COMPLETE FEM POR L STD
• Common Device Name: LCS COMPLETE : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14914138
• Report Number: 1818910-2022-12247
• Device Sequence Number: 1989845
• Product Code: NJL
• UDI-Device Identifier: 10603295021766
• UDI-Public: 10603295021766
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/05/2022

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: 1294-04-040
• Device Catalogue Number: 129404040
• Device Lot Number: 8173908
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2022
• Initial Report FDA Received Date: 07/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LCS COMP RP INSERT STD 10MM; LCS COMPLETE FEM POR L STD; MBT POR TIBIAL TRAY SZ3
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown