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

Catalog Number UNK HIP ACETABULAR CUP

Device Problem Naturally Worn (2988)

Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Osteolysis (2377); Test Result (2695); Not Applicable (3189); No Code Available (3191)

Event Date 01/01/2016

Event Type  Injury  

Manufacturer Narrative

(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

The literature article entitled, "histopathological characterization of corrosion product associated adverse local tissue reaction in hip implants: a study of 285 cases" written by benjamin f.Ricciardi, allina a.Nocon, seth a.Jerabek, gabrielle wilner, elianna kaplowitz, steven r.Goldring, p.Edward purdue and giorgio perino published by bmc clinical pathology ricciardi et al.Bmc clinical pathology (2016) 16:3 doi 10.1186/s12907-016-0025-9 was reviewed.The article's purpose: "the purpose of this study was to describe the histological patterns observed in the periprosthetic tissue of failed tha in three different implant classes due to altr and their association with clinical features of implant failure." depuy products utilized: asr resurfacing, asr xl, pinnacle ultramet, mom bearing srom - all retrieved as failures due to altr - all bearing surfaces mom.Adverse events: soft tissue necrosis, metallic and black particles (debris contributed to wear and corrosion), device corrosion, osteolysis (contributed to foreign body debris), hypersensitivity (noted by increased macrophages, lymphocytes, eosinophils), elevated blood ion levels ranging 0-169 co and 0-64 cr.As the article does not specify which product platforms are associated with specific adverse events, platforms are grouped and captured as 1 impacted product for each product type.The article does not provided adequate information to determine accurate quantities.

Manufacturer Narrative

Product complaint # (b)(4).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 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• 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): DEPUY INT'L LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6103142063
• MDR Report Key: 9342268
• MDR Text Key: 185010406
• Report Number: 1818910-2019-115026
• 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
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 10/29/2019

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 ACETABULAR CUP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/29/2019
• Initial Date FDA Received: 11/19/2019
• Supplement Dates Manufacturer Received: 12/23/2019
• Supplement Dates FDA Received: 12/23/2019
• 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