MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL HEAD

Catalog Number UNK HIP FEMORAL HEAD

Device Problem Corroded (1131)

Patient Problems Edema (1820); Foreign Body Reaction (1868); Pain (1994); No Code Available (3191)

Event Date 07/19/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter occupation: lawyer.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Pinnacle claim submission form and medical records received.After review of medical records, the patient was revised to address trunnionosis.Workup was negative for infection and negative for loosening.Surgeon states that the patient's cobalt levels were elevated, but lab result was below 7.There was a moderate amount of fluid in the joint sent for metal ion testing.Chromium level in the fluid was 810 mcg/l and chromium was 440 mcg/l.There were black marks from the trunnionosis on the head and neck taper junction from the friction of the metal on metal components.Clinic visit on (b)(6) 2018 indicates that the patient has been experiencing chronic right hip pain, x-rays which showed possible loosening, chromium at 1.5 and cobalt at 4.6.The physician suspects corrosion due to a metal head prosthesis.Doi: (b)(6) 2016; dor: (b)(6) 2018 (right hip).

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.Product complaint # (b)(4).Investigation summary :.No device associated with this report was received for examination.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot : null.Device history batch : null.Device history review : null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN HIP FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9828953
• MDR Text Key: 188220592
• Report Number: 1818910-2020-07740
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 02/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: POLYETHYLENE LINER UNKNOWN PART/LOT; UNKNOWN PART/LOT; UNKNOWN PART/LOT
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Weight: 88