MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 UNK HIP FEMORAL HEAD METAL ASR; METAL FEMORAL HEAD

Catalog Number UNK HIP FEMORAL HEAD METAL ASR

Device Problem Naturally Worn (2988)

Patient Problems Dysphagia/ Odynophagia (1815); Fatigue (1849); Foreign Body Reaction (1868); Memory Loss/Impairment (1958); Pain (1994); Loss of Range of Motion (2032); Anxiety (2328); Distress (2329); Discomfort (2330); Depression (2361); Numbness (2415); Ambulation Difficulties (2544); Confusion/ Disorientation (2553); Unspecified Mental, Emotional or Behavioural Problem (4430); Metal Related Pathology (4530)

Event Date 01/24/2017

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.H6 component code: appropriate term/code not available (g07002) used to capture no findings available.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.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: green b, griffiths e, almond s.Neuropsychiatric symptoms following metal-on-metal implant failure with cobalt and chromium toxicity.Bmc psychiatry.2017 jan 24;17(1):33.Doi: 10.1186/s12888-016-1174-1.Pmid: 28114963; pmcid: pmc5259873.Objective and methods: there were at least 31,171 metal-on-metal (mom) hip implants in the uk between 2003 and 2011.Some of these were subject to failure and widescale recalls and revisions followed.This is a study of 10 cases (mean age 60 years) where the authors evaluated neuropsychiatric complications following metal-on-metal asr xl hip implant failure, toxicity of cobalt and chromium ions in the blood, and revision between 2005 and 2009.All 10 patients had revision surgery performed between 2008 and 2012 and received a psychiatric evaluation in 2014/15.All patients had toxic levels of co and cr in the blood, as well as metallosis.At the end of the study, the authors found neurocognitive and depressive deficits after cobalt and chromium metallosis following mom asr xl implant failure.This complaint will capture the generalized results for five patients as well as 4 patient specific results.Lot, model and catalog number are not available, but the suspected depuy device possibly associated with reported adverse events: depuy asr- xl including a cup, femoral head, femoral sleeve, and unk femoral stem component.Adverse event(s) and provided interventions associated with depuy devices: generalized results: 9 patients had toxic blood heavy metal ions cr range 144-664 ppb and co 184-2470 ppb.6 patients were revised and had depression, dementia, cognitive changes, anxiety, irritability, emotional distress, walking difficulty, memory impairment, pain, sleep dysfunction, dysphagia, confusion/disorientation, metallosis, metal debris/wear, blood heavy metal increased, metal poisoning, weakness, fatigue, medical device site joint movement impairment, discomfort, numbness.Mrs.Z: 58 year old female with right asr-xl: she had pre-revision chrome levels of 326 nmol/l and cobalt levels of 544 nmol/l, metal wear, metallosis, anxiety, depression, cognitive changes, irritability, emotional distress, walking difficulty, memory impairment, pain, sleep dysfunction, dysphagia, confusion/disorientation, blood heavy metal increased, metal poisoning, weakness, fatigue, medical device site joint movement impairment, discomfort, numbness, disoriented to person, cognitive abnormalities and a mmse score of 17 indicating dementia, and a significantly elevated beck depression inventory score of 38 after treatment with escitalopram.

• Brand Name: UNK HIP FEMORAL HEAD METAL ASR
• Type of Device: METAL FEMORAL HEAD
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• 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: 17278709
• MDR Text Key: 318641561
• Report Number: 1818910-2023-13722
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 07/07/2023

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 Catalogue Number: UNK HIP FEMORAL HEAD METAL ASR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/19/2023
• Initial Date FDA Received: 07/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention