MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM M HEAD 36MM +3; S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS

Catalog Number	136532000
Medical Device Problem Codes	Degraded (1153); Device Dislodged or Dislocated (2923); Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Joint Dislocation (2374); Joint Laxity (4526)
Date of Event	02/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).H6 component code: appropriate term/code not available (g07002) used to capture no findings available.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.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
Thayer school of engineering at dartmouth first report of retrievals for statement of work 10 for q2 of 2024.A depuy synthes implant was revised and reviewed for analysis.Reason for revision: revision due to dislocation, instability, metal wear, pain, implant loosening, and subsidence -unknown implant(s).At revision corrosion was noted on the femoral head.Doi: (b)(6) 2007.Doe: 26-feb-2024.

• Brand Name: S-ROM M HEAD 36MM +3
• 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): LEEDS MFG & MATERIAL WAREHOUSE; st anthonys road; leeds ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 19843193
• Report Number: 1818910-2024-16098
• Device Sequence Number: 7666481
• Product Code: LPH
• UDI-Device Identifier: 10603295033387
• UDI-Public: (01)10603295033387(17)111018(10)2253173
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K120599
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/26/2024

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: 10/18/2011
• Device Catalogue Number: 136532000
• Device Lot Number: 2253173
• 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: 07/15/2024
• Initial Report FDA Received Date: 07/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/07/2001
• 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: S-ROM*SLEEVE PRX ZTT, 16D-LRG; UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP ACETABULAR LINERS; UNKNOWN HIP FEMORAL STEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown