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

Catalog Number	129402050
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Use of Device Problem (1670)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Pain (1994)
Date of Event	04/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.
Event or Problem Description
Revision of lcs implants.Implants loosened due to poor positioning during initial primary procedure.There was metalosis showing in the joint.Implants were taken out very easily.Exact date unknown.
Event or Problem Description
Additional information was received.Indicating, that there was loosening between the implant and cement.
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.Corrected: h6: (device code).Pe code, was updated from implant loosening: interface: unknown to implant loosening: interface: cement to implant.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: according to the information received, ¿revision of lcs implants.Original surgery year was [year].Implants loosened due to poor positioning during initial primary procedure.There was metalosis showing in the joint.Implants were taken out very easily.Exact date unknown¿ the product was not returned to depuy synthes, however photos were provided for review.See attachments "revision (b)(6).Jpg" and "revision (b)(6)2.Jpg" review of the photographic evidence revealed that a large portion of the fixation surface presents signs of what appears to be cement, which may indicate a proper fixation between the implant and the femoral bone.However, based on the available information, the reported loose condition cannot be confirmed and it is not possible to determine the exact position in which the lcs complete fem cem l std+ was implanted.A manufacturing record evaluation was performed for the finished device [129402050 / 3462542] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.The overall complaint was not confirmed as the observed condition of the lcs complete fem cem l std+ would not contribute to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: a manufacturing record evaluation was performed for the finished device [129402050 / 3462542] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.

• Brand Name: LCS COMPLETE 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): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 19272080
• Report Number: 1818910-2024-10181
• Device Sequence Number: 20574871
• Product Code: NJL
• UDI-Device Identifier: 10603295021636
• UDI-Public: 10603295021636
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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

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: 05/31/2022
• Device Catalogue Number: 129402050
• Device Lot Number: 3462542
• 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: 04/29/2024
• Supplement Date Received by Manufacturer: 05/07/2024; 05/21/2024
• Initial Report FDA Received Date: 05/08/2024
• Supplement Report FDA Received Date: 05/16/2024; 05/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2012
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LCS COMP RP INSERT STD+ 10MM.; MBT CEM TIBIAL TRAY SZ4.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown