MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DURALOC CONST LINER 54X32; DURALOC IMPLANT : HIP POLY ACETABULAR LINERS

Catalog Number	124214527
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Type of Reportable Event	Serious Injury
Event or Problem Description
Subject id: (b)(4).Study no: dots clinical adverse events received for dislocation - reoccurrence device and procedure(relatedness) device related: possibly procedure related: probably date of event: 15/nov/2024 date of implant: no information provided date of revision: no information provided device location: left treatment/impact: no information provided depuy synthes product used: catalog id: 124603000 lot id: u55hm1000 component type: acc description: apex hole elim positive stop.Catalog id: 124754000 lot id: uc8a41024 component type: shell description: duraloc shell 100 series 54mm catalog id: 521423 lot id: 642458 component type: sleeve description: srom sleeve prox ztt 22b sm catalog id: 523422 lot id: 822029 component type: stem description: srom stem std 36mm +8l neck 22mm x 17mm x165mm.Catalog id: 124954000 lot id: m6081k component type: ring description: duraloc dynamic lock ring 54mm catalog id: 875956 lot id: 3770845 component type: head description: srom head 32mm + 9mm catalog id: 124954000 lot id: m5355c component type: ring description: duraloc dynamic lock ring 54mm catalog id: 124214527 lot id: m2068y component type: liner description: duraloc liner constrained 54mm x 32mm.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy orthopaedics is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy orthopaedics has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy orthopaedics or its employees that the report constitutes an admission that the device, depuy orthopaedics, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint #(b)(4).Investigation summary: no device associated with this report was received for examination.The adverse symptoms alleged and product code reported is associated with the depuy metal on metal articulation.A complaint database search and/or device manufacturing (dhr) reviews will not be performed.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.Device history lot: a manufacturing record evaluation (mre) will not be performed since mom systems are obsolete.Added: d6a.Corrected: d6b, h6 health effect - impact code.

• Brand Name: DURALOC CONST LINER 54X32
• Common Device Name: DURALOC IMPLANT : HIP POLY ACETABULAR LINERS
• 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: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 21403112
• Report Number: 1818910-2025-02662
• Device Sequence Number: 13090857
• Product Code: KWZ
• UDI-Device Identifier: 10603295019176
• UDI-Public: (01)10603295019176(17)271130(10)M2068Y
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P960054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2000
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,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 Catalogue Number: 124214527
• Device Lot Number: M2068Y
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2025
• Supplement Date Received by Manufacturer: 02/24/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/16/2022
• 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: 53 YR
• Patient Sex: Male
• Patient Weight: 82 KG