MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 UNK HIP ACETABULAR CUP ASR

Catalog Number UNK HIP ACETABULAR CUP ASR

Device Problem Naturally Worn (2988)

Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Synovitis (2094); Metal Related Pathology (4530)

Event Date 01/01/2024

Event Type  Injury  

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: sheridan ga, neufeld me, sidhu a, kurmis ap, kelly m, o'byrne jm, howard lc, masri ba, garbuz ds.The diagnostic utility of serum metal ion markers for high-grade aseptic lymphocyte-dominated vasculitis-associated lesions (alvals) in revision hip and knee arthroplasty: an international multicenter study.J arthroplasty.2024 jan;39(1):206-210.Doi: 10.1016/j.Arth.2023.06.024.Epub 2023 jun 16.Pmid: 37331438.Objective and methods: aseptic lymphocyte-dominated vasculitis-associated lesions (alvals) are typically described in the context of metal-on-metal (mom) hip bearings.This study explores the diagnostic utility of preoperative serum cobalt and chromium ion levels in determining the histological grade of alval in revision hip and knee arthroplasty.This was a multicenter retrospective review of 26 hips and 13 knees assessing the correlation between preoperative ion levels (mg/l (ppb)) and the histological grade of alval from intraoperative specimens.All metal ion levels were recorded within 3 months of the revision surgery.The cobalt: chromium (co:cr) ratio was also calculated based on these levels.All revision surgery was performed between january 1, 2011 and december 31, 2022.All revision procedures were performed at varying time intervals from the index procedure in hospitals located in canada, australia, and dublin, ireland.The article does not specify which revisions occurred in each country of event.Results: the depuy products revised in the study included 9 asr hip resurfacing constructs (head and cup), 1 duraloc/corail tha construct (cup, head, liner, and stem), 2 lcs and 1 attune tkas (femoral, insert, tibial tray).There is no indication that the patellas were resurfaced and the manufacturer of the cement utilized in the tkas was not provided.The results for the competitor constructs will be excluded from this complaint.The indications for all tha revisions were symptomatic armd and for the tkas was aseptic loosening.Histologic samples taken from the revision procedures identified synovitis, metallosis, metal debris (hips only), and pseudotumor.Additionally, serum cobalt and chromium levels were confirmed to be elevated above 7 ppb.

Manufacturer Narrative

Product complaint # (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.An evaluation of the manufacturing record could not be performed as the required lot number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot : the device lot number is unknown, therefore a device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : updated 4/11/2024.No device associated with this report was received for examination.The asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot : the device lot number is unknown, therefore a device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.Wwcapa 00780 superseded by mdd capa-001226 was established regarding root cause and/or corrective actions.Reference: mdd capa-001226.

• Brand Name: UNK HIP ACETABULAR CUP ASR
• Type of Device: HIP ACETABULAR CUP
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): LEEDS MFG & MATERIAL WAREHOUSE; st anthonys road; leeds
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18885791
• MDR Text Key: 337435781
• Report Number: 1818910-2024-05586
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP ACETABULAR CUP ASR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/11/2024
• 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