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

Catalog Number	129405410
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)
Date of Event	02/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
This complaint is from a literature source.The following literature cite has been reviewed: schoutens c, nolte pa, van noort a.Traumatic anterior tibiofemoral dislocation of mobile-bearing total knee arthroplasty: two cases.Trauma case rep.2025 feb 17;56:101144.Doi: 10.1016/j.Tcr.2025.101144.Pmid: 40083388; pmcid: pmc11904596.Objective/methods/study data: this study presents 2 cases; case 1: a 71-year-old caucasian woman presented to the emergency department after a fall from stance onto the floor in the domestic setting, in which hyperextension of her left prosthetic knee joint had probably occurred.A lcs complete¿ cementless rotating platform tka had been implanted fifteen years prior for symptomatic lateral osteoarthritis.Case 2: a 73-year-old caucasian woman presented to the emergency room after slipping on an oil spill and falling directly onto her left knee.She was in severe pain, could not bear weight, and had a deformed left knee joint.A left lsc complete¿ cementless rotating platform tka had been implanted 8 years prior for symptomatic osteoarthritis in an uncomplicated procedure.Lot, model and catalog numbers are not available, but the suspected depuy synthes device(s) possibly associated with reported adverse events: lcs complete¿ rotating platform cementless; depuy, warsaw, in).Adverse event(s) and provided interventions possibly associated with unk knee femoral lcs (qty: 1) ip-02571802: 71-year-old caucasian woman: pain, walking difficulty, surgical intervention, joint dislocation.Adverse event(s) and provided interventions possibly associated with unk knee tibial insert lcs (qty:1) ip-02571803: 71-year-old caucasian woman: pain, walking difficulty, surgical intervention, joint dislocation.Adverse event(s) and provided interventions possibly associated with unk knee femoral lcs (qty: 1) ip-02571804: 73-year-old caucasian woman: pain, swelling, walking difficulty, surgical intervention, device revision or replacement, soft tissue injury, joint instability.Adverse event(s) and provided interventions possibly associated with unk knee tibial insert lcs (qty: 1) ip-02573334: 73-year-old caucasian woman: pain, swelling, walking difficulty, surgical intervention, device revision or replacement, soft tissue injury, and joint instability.
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.H11 additional manufacturer narrative: d4: udi: as the catalog/model number was not provided, the (01) gtin is not available.
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.H11 additional narrative: added: d4 (lot, catalog, expiry date), g4 ( pma/ 510(k)), h4.Corrected: d1, d2a, d4 (primary udi number).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- no device associated with this report was received for examination.This complaint was opened to document complaints derived through a journal article review.Follow-ups were done to try and obtain additional information from the author of the journal article.No further information was received.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.

• Brand Name: LCS COMP RP INSERT STD 10MM
• Common Device Name: 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 46582
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 23630383
• Report Number: 1818910-2025-20611
• Device Sequence Number: 15836978
• Product Code: NJL
• UDI-Device Identifier: 10603295022015
• UDI-Public: (01)10603295022015(17)190601(10)550834
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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,Literature,Health Professional
• Initial Reporter Occupation: Physician
• 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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/01/2019
• Device Catalogue Number: 129405410
• Device Lot Number: 550834
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/03/2025
• Supplement Date Received by Manufacturer: 11/25/2025; 12/04/2025
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 12/03/2025; 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/12/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Race: White