MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM M HEAD 36MM +6; S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS

Catalog Number	136533000
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Foreign Body Reaction (1868)
Date of Event	04/04/2024
Type of Reportable Event	Malfunction
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
Subject id: (b)(6).Study no: dots.Clinical adverse event received for adverse reaction to metal debris.Event is not serious and is considered moderate.Event is possibly related to device.Event is not related to procedure.Date of implant: (b)(6) 2010.Date of event: 04 apr 2024.(right hip).Treatment: none.Additional event information: revision due to metal wear.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary no device associated with this report was received for examination.A search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product (part #136533000>/lot #2538540) combination.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 search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product (part #136533000>/lot #2538540) combination.

• Brand Name: S-ROM M HEAD 36MM +6
• 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): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 19518556
• Report Number: 1818910-2024-12751
• Device Sequence Number: 8412148
• Product Code: LPH
• UDI-Device Identifier: 10603295033509
• UDI-Public: 10603295033509
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K120599
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/16/2013
• Device Catalogue Number: 136533000
• Device Lot Number: 2538540
• 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: 05/22/2024
• Supplement Date Received by Manufacturer: 06/17/2024
• Initial Report FDA Received Date: 06/12/2024
• Supplement Report FDA Received Date: 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/24/2008
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: APEX HOLE ELIM POSITIVE STOP.; PINNACLE 100 ACET CUP 52MM.; PINNACLE MTL INS NEUT36IDX52OD.; S-ROM*SLEEVE PRX ZTT, 18D-LRG.; SROM STM STD 36+12L 13X18.
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Race: White