MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LCS COMP MOD REV FEM CEM R LG; LCS REVISION : KNEE FEMORAL

Model Number	1294-41-060
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Fall (1848)
Date of Event	05/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision completed after patient suffered a fall.The lcs femoral implant snapped.Surgeon thought it could be stress shielding.
Additional Manufacturer Narrative
Product complaint #pc-(b)(4).
Additional Manufacturer Narrative
Product complaint #(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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 report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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 report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : the product was returned to depuy synthes and sent to warsaw for a metallurgy evaluation.Visual examination found brakeage on the medial aspect of the device.Confirming the reported allegation.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.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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 report, a follow-up report will be filed as appropriate.
Event or Problem Description
Additional information was received and mentioned that the device was worn down and fractured during the visual examination performed on (b)(6) 2023.

• Brand Name: LCS COMP MOD REV FEM CEM R LG
• Common Device Name: LCS REVISION : 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: 14619555
• Report Number: 1818910-2022-10212
• Device Sequence Number: 4509309
• Product Code: JWH
• UDI-Device Identifier: 10603295026112
• UDI-Public: 10603295026112
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• 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,Followup,Followup,Followup,Followup
• Report Date (Section B): 06/07/2022

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 Expiration Date: 11/25/2014
• Device Model Number: 1294-41-060
• Device Catalogue Number: 129441060
• Device Lot Number: 3031475
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2022
• Supplement Date Received by Manufacturer: 08/18/2022; 08/30/2022; 10/14/2022; 01/26/2023
• Initial Report FDA Received Date: 06/07/2022
• Supplement Report FDA Received Date: 08/22/2022; 09/06/2022; 10/17/2022; 01/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/26/2009
• 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 COM POST AUG 10MM LG; LCS COM POST AUG 10MM LG; LCS COM POST AUG 10MM LG; LCS COM POST AUG 10MM LG; LCS COMP MOD REV FEM CEM R LG; LCS COMP RP INSERT LG 10MM; LCS COMP RP INSERT LG 10MM; MBT REVISION CEM TIB TRAY SZ 5; MBT REVISION CEM TIB TRAY SZ 5; UNIVERSAL STEM 75X20MM FLUTED; UNIVERSAL STEM 75X20MM FLUTED; UNKNOWN BONE CEMENT; UNKNOWN BONE CEMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male