MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HIP ACETABULAR LINER METAL; METAL ACETABULAR LINER

Catalog Number UNK HIP LINER METAL

Device Problem Noise, Audible (3273)

Patient Problems Fatigue (1849); Foreign Body Reaction (1868); Pain (1994); Loss of Range of Motion (2032); Anxiety (2328); Ambulation Difficulties (2544); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/01/2020

Event Type  Injury  

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.Remedial actn initiated othr type 2nd.

Event Description

The patient has a left metal on metal hip since in 2008, the hip has been making grinding noises and has been leaking metals (ions) into my blood for over 12 years, these metals are called cobalt and chromium, these metals are in my blood system.This is called metal poisoning.(metallosis), in the last 2 years, the pain in my left hip and leg has gotten worse to the point that i have had to stop walking because of excruciating pain to my hip on many occasions, i also started to experience fatigue depression, anxiety attacks, pain in left leg, mobility issues, breathing difficulties when walking, kidney damage, liver damage, thyroid problems and metal poisoning to blood and endocrine system, vision worse.My ion levels are very high, cobalt is 574 nmol/l and chromium is 650 nmol/l,within the past four months my eyesight has gotten w orse, my anxiety levels and breathlessness have increased and so has my mobility has lessened and is deteriorating.

Manufacturer Narrative

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 : the alleged adverse symptoms, and the product code reported, are associated with the articulation between depuy metal-on-metal products.Per wi-3430, it has been determined that should additional reports be identified for related metal-on-metal complications, a device history record (dhr) review is not required.Therefore, a complaint database search and/or device manufacturing review will not be performed for the reported product associated with this investigation.

• Brand Name: UNK HIP ACETABULAR LINER METAL
• Type of Device: METAL ACETABULAR LINER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12212117
• MDR Text Key: 262960581
• Report Number: 1818910-2021-15777
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 06/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP LINER METAL
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK HIP ACETABULAR LINER METAL; UNK HIP FEMORAL HEAD METAL; UNKNOWN HIP FEMORAL STEM; UNK HIP ACETABULAR LINER METAL; UNK HIP FEMORAL HEAD METAL; UNKNOWN HIP FEMORAL STEM
• Patient Outcome(s): Required Intervention