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 Problems Degraded (1153); Naturally Worn (2988); Osseointegration Problem (3003)

Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Necrosis (1971); Pain (1994); Osteolysis (2377); Inadequate Osseointegration (2646); Metal Related Pathology (4530)

Event Date 04/06/2021

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.The size of the article is too large to attach/submit with the 3500a submission.The citation of the article has been provided below: campbell p, park sh, ebramzadeh e.Semi-quantitative histology confirms that the macrophage is the predominant cell type in metal-on-metal hip tissues.J orthop res.2022 feb;40(2):387-395.Doi: 10.1002/jor.25040.Epub 2021 apr 6.Pmid: 33749015; pmcid: pmc9292819.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: campbell p, park sh, ebramzadeh e.Semi-quantitative histology confirms that the macrophage is the predominant cell type in metal-on-metal hip tissues.J orthop res.2022 feb;40(2):387-395.Doi: 10.1002/jor.25040.Epub 2021 apr 6.Pmid: 33749015; pmcid: pmc9292819.Objective and methods: numerous studies have examined the histology of metal-on-metal hip tissues for evidence of a dose response to metal wear but have often reported inconclusive or contradictory findings.The aim of the present study was to address these discrepancies using multiple histological scoring methods to characterize the tissue features of one large group of revised metal-on-metal total hips.Periprosthetic tissues from 165 asr xl metal-on-metal hip revisions (dor 2011 to 2017) were examined for features of aseptic lymphocytic vasculitis associated lesions (alval) as rated using two scoring systems as well as rankings for macrophage and lymphocyte numbers, intracellular wear debris and necrosis.This complaint will capture the generalized results of the pathological and histological studies of the explanted products and tissue samples as well as two 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 component femoral sleeve, and unk depuy femoral stem.Adverse event(s) and provided interventions associated with depuy devices: generalized results: all 165 patients were revised to treat alval, soft tissue necrosis, metal wear, elevated blood metal ions, and corrosion at the stem/head trunnion junction.The following were additional findings during the revisions: 86 pain, 62 elevated blood metal ions, 24 unspecified loosening, 19 metallosis, 14 pseudotumor (hypersensitivity) , 6 osteolysis, 4 infection, 2 allergic reaction, tissue pathology results: 23 samples with identified tissue necrosis.

• 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: 17279474
• MDR Text Key: 318756525
• Report Number: 1818910-2023-13729
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: 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