MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 LCS COMP RPSFLEX FEM CEM L STD; LCS COMPLETE : KNEE FEMORAL

Model Number	1294-12-040
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Synovitis (2094)
Date of Event	02/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Medical records ad (b)(6) 2023, were reviewed by a clinician.Patient underwent a left total knee arthroplasty utilizing depuy synthes implants on (b)(6) 2013, including patella.Competitor cement was utilized.On (b)(6) 2023, the patient underwent a left total knee revision for loosening.Dark staining of the synovium was present with extensive metallosis.The femoral component was loose with no interface clearly provided.The tibial component was also loose at the implant to cement interface.The patella was undersized according to the surgeon and was revised.Doi: (b)(6) 2013.Dor: (b)(6) 2023.Left knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).E3 initial reporter occupation: (b)(6).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.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.

• Brand Name: LCS COMP RPSFLEX FEM CEM L STD
• Common Device Name: LCS COMPLETE : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• 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: 17208747
• Report Number: 1818910-2023-13106
• Device Sequence Number: 12428867
• Product Code: NJL
• UDI-Device Identifier: 10603295022923
• UDI-Public: 10603295022923
• 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: 2013
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 06/27/2023

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 Expiration Date: 09/30/2022
• Device Model Number: 1294-12-040
• Device Catalogue Number: 129412040
• Device Lot Number: 3517438
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2023
• Initial Report FDA Received Date: 06/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2012
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1672-2015
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LCS COMP RPS INS STD 17.5MM.; LCS COMPLETE LO PRO POLPAT STD.; MBT CEM KEEL TIB TRAY SZ3.; ZIMMER CEMENT.; ZIMMER CEMENT.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female