MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM HEAD FEMORAL COCR 32+9; S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS

Catalog Number	875956
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Type of Reportable Event	Serious Injury
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.
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).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: S-ROM HEAD FEMORAL COCR 32+9
• Common Device Name: S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS
• 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: 21405504
• Report Number: 1818910-2025-02661
• Device Sequence Number: 8524219
• Product Code: JDI
• UDI-Device Identifier: 10603295218869
• UDI-Public: (01)10603295218869(17)270331(10)3770845
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K920317
• 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: 875956
• Device Lot Number: 3770845
• 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: 04/12/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: APEX HOLE ELIM POSITIVE STOP; DURALOC 100 SERIES 54MM OD; DURALOC DYNAMIC LOCK RING 54MM; DURALOC DYNAMIC LOCK RING 54MM; S-ROM*SLEEVE PRX ZTT, 22B-SML; SROM*STM ST,36+8L NK,22X17X165
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 82 KG