MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 11/13 S-ROM 40MM M SPEC+3; S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS

Catalog Number 136543500

Device Problems Corroded (1131); Naturally Worn (2988)

Patient Problems Death (1802); Foreign Body Reaction (1868); Pain (1994); Tissue Damage (2104); Distress (2329); Injury (2348); No Code Available (3191)

Event Date 01/14/2019

Event Type  Death  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.(b)(4).

Event Description

It was reported that the pinnacle metal liner and srom metal head were removed from the left hip on (b)(6) 2019, because of metallosis.The date of implant is unknown.

Event Description

Litigation alleges elevated metal ions, wear, soft tissue injury, bone damage, pain, emotional distress and death.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Additional narrative: patient code: no code available (3191) used to capture the blood heavy metal.

Manufacturer Narrative

Product complaint # (b)(4).No device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Corrective action was not indicated.

• Brand Name: 11/13 S-ROM 40MM M SPEC+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 46582 0988
• MDR Report Key: 8305119
• MDR Text Key: 135007638
• Report Number: 1818910-2019-83274
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295033776
• UDI-Public: 10603295033776
• Combination Product (y/n): N
• PMA/PMN Number: K060031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 136543500
• Device Lot Number: 2937498
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 63 YR