MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LCS COMP RP INSERT STD+ 10MM; LCS COMPLETE : KNEE TIBIAL INSERT

Catalog Number	129405510
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	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.
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 that 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
It was indicated that there was loosening.On what interface did the loosening occur? ¿ loosening between the implant and cement.
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 29 april.Jpg" and "revision 29 april2.Jpg".Review of the photographic evidence revealed that lcs comp rp insert std+ 10mm has the central post that attaches to the tibial tray fracture; however, it cannot be determined whether this fracture occurred prior to or after the extraction process.Additionally, sings of what appears to be extraction marks were observed on the articulating surface of the lcs comp rp insert std+ 10mm.No other defects that could have contributed to the reported event were observed.The overall complaint was not confirmed as the observed condition of the lcs comp rp insert std+ 10mm would not contribute to the complained event.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: 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.

• Brand Name: LCS COMP RP INSERT STD+ 10MM
• Common Device Name: LCS COMPLETE : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 19271704
• Report Number: 1818910-2024-10179
• Device Sequence Number: 15212346
• Product Code: NJL
• UDI-Device Identifier: 10603295022084
• UDI-Public: 10603295022084
• 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
• Report Date (Section B): 05/08/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2017
• Device Catalogue Number: 129405510
• Device Lot Number: 226520
• 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: 05/08/2024; 05/21/2024
• Initial Report FDA Received Date: 05/08/2024
• Supplement Report FDA Received Date: 05/13/2024; 05/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2012
• 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 COMPLETE FEM CEM L STD+; MBT CEM TIBIAL TRAY SZ4
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown