MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 UNK HIP FEMORAL STEM CORAIL

Catalog Number UNK HIP FEMORAL STEM CORAIL

Device Problem Naturally Worn (2988)

Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Metal Related Pathology (4530)

Event Date 09/28/2018

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.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: ahmed ss, bawale r, jain s, samsani s.Metal ion levels comparison: metal-on-metal hip resurfacing vs total hip arthroplasty in patients requiring revision surgery.J orthop.2018 sep 28;15(4):1013-1016.Doi: 10.1016/j.Jor.2018.09.002.Pmid: 30319224; pmcid: pmc6180337.Objective and methods: the purpose of this study was to compare the reasons for revision of 104 patients who received either a mom tha (54) or mom hra (50) between 2009 and 2014.All thas were a depuy pinnacle/corail metal on metal hip.The resurfacing group received either a depuy asr or a construct manufactured by a competitor.To be included, all the patients were revised to treat symptomatic mom disease including pain, elevated blood metal ions, pseudotumor, metallosis, and evidence of armd.The meal level of serum cobalt was 24 ppb and 28.23 ppb in the tha and hra respectively.The meal serum levels of chromium were 13.24 ppb and 19.67 ppb in the tha and hra respectively.All 104 constructs were revised.As there is insufficient information to determine how many depuy asr hras were revised, the quantity will be captured as 1.The depuy pinnacle cup will be excluded as it is reasonable to attribute the results to known complications of metal-on-metal articulating surfaces and stem/head trunnion micromotion.Lot, model and catalog number are not available, but the suspected depuy device possibly associated with reported adverse events: depuy asr including a cup and femoral component.Pinnacle metal liner, unk metal femoral head, and corail femoral stem.Adverse event(s) and provided interventions associated with depuy devices: 54 revisions of the pinnacle liner, unk femoral head, and corail stem to treat pain, pseudotumor, armd, metallosis, and elevated blood metal ions.Unknown number of depuy asr revisions to treat pain, pseudotumor, armd, metallosis, and elevated blood metal ions.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.This complaint was opened to document complaints derived through a journal article review.Follow-ups were done to try and obtain additional information from the author of the journal article.No further information was received.Device history lot : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Brand Name: UNK HIP FEMORAL STEM CORAIL
• Type of Device: FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 17209887
• MDR Text Key: 317989058
• Report Number: 1818910-2023-13138
• Device Sequence Number: 1
• Product Code: LZO
• 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
• Type of Report: Initial,Followup
• Report Date: 06/27/2023

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 STEM CORAIL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/17/2023
• Initial Date FDA Received: 06/27/2023
• Supplement Dates Manufacturer Received: 06/30/2023
• Supplement Dates FDA Received: 07/03/2023
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention