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

Device Problems Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cyst(s) (1800); Foreign Body Reaction (1868); Pain (1994); Swelling/ Edema (4577)

Event Date 01/01/2023

Event Type  Injury  

Event Description

Clinical adverse event received for revision; altr.Event is serious and is considered severe.Event is possibly related to device.Event is not related to procedure.Date of implant: (b)(6) 2006; date of revision: (b)(6) 2023; date of event: (b)(6) 2023; (right hip).Treatment: revision; head and liner were revised.

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.

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 the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.H10 additional narrative:.

Event Description

Medical record received.On (b)(6) 2023, the patient had a revision right total hip to address pain, swelling, and bearing wear.The patient was noted to have had a previous metal on metal hip arthroplasty completed on (b)(6) 2006.During the current revision the surgeon observed blue-black synovial fluid, compatible with metallosis.The surgeon also noted an anterosuperior cyst which was debrided.There was considerable backside synovial foreign body metallosis reaction noted.Metal head and liner were removed and replaced with ceramic head and poly liner.Depuy components were implanted during this procedure.

• Brand Name: S-ROM M HEAD 36MM +3
• Type of Device: 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): DEPUY INT'L LTD. 8010379; st anthonys road; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 17833520
• MDR Text Key: 324461865
• Report Number: 1818910-2023-19635
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295033387
• UDI-Public: 10603295033387
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120599
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/27/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 12/15/2010
• Device Catalogue Number: 136532000
• Device Lot Number: 2037617
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/15/2023
• Initial Date FDA Received: 09/28/2023
• Supplement Dates Manufacturer Received: 10/03/2023
• Supplement Dates FDA Received: 10/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2005
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: APEX HOLE ELIM POSITIVE STOP; PINNACLE 100 ACET CUP 56MM; PINNACLE MTL INS NEUT36IDX56OD; S-ROM M HEAD 36MM +3; S-ROM*STM STD,42 NK,22X17X165
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 125 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White