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

Catalog Number UNK HIP ACETABULAR CUP

Device Problems Naturally Worn (2988); Noise, Audible (3273)

Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); No Code Available (3191)

Event Date 09/03/2014

Event Type  Injury  

Manufacturer Narrative

Product complaint (b)(4).Investigation summary: the asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.Further investigation of this individual incident will not be undertaken.The investigation regarding the root cause(s) and/or corrective actions was conducted under mdd capa-(b)(4).Ongoing post market surveillance is conducted per our procedures for this product.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

Literature article entitled, ¿the inflammatory phenotype in failed metal-on-metal hip arthroplasty correlates with blood metal concentrations¿ by erja-leena paukkeri, et al, published by plos one (2016), vol.11, no.5, 13 pages, doi:10.1371/journal.Pone.015512, was reviewed.In the present study, the authors aimed to have another approach to investigate and understand the cell types and mechanisms involved in armd by utilizing flow cytometry to further characterize the tissue reaction in failed mom implants using tissue obtained from asr revisions as an example.Implanted products: there were 4 asr resurfacing systems and 12 asr-xl systems studied in this article.Results: each of the 16 implants studied was revised.The revisions were divided into 1) revised due to pseudotumor, 2) revised due to elevated blood metal ions, and 3) revised due to unspecified ¿symptoms¿ that included pain, joint instability, and/or decreased joint range of motion.Every patient in the study had intraoperative confirmation of pseudotumor, soft tissue necrosis, and armd.The authors confirm that each patient had histologically confirmed elevated inflammatory markers, but there were no cases of infection identified.This complaint captures 16 total patients labeled cases 1-case 16 on the attached guidance sheet.Each case identifies the specific implant and associated events.Please link all related pcs to this parent (b)(4).(b)(6) female patient with asr hemiarthroplasty.Revised 63 months after index tha due to elevated blood metal ions- co.113.3 ppb and cr.45.2 ppb, pseudotumor, and "symptoms" including pain, joint instability, decreased joint range of motion, and/or joint noise.Pseudotumor, armd, and soft tissue necrosis confirmed intraoperatively.

• Brand Name: UNKNOWN HIP ACETABULAR CUP
• 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 LS11 8DT; UK LS11 8DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9276346
• MDR Text Key: 184861545
• Report Number: 1818910-2019-111658
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 10/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2019
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2019
• 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