MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ASR ACETABULAR IMPLANT 56; ASR HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number 999804956

Device Problems Unintended Movement (3026); Migration (4003)

Patient Problems Hypersensitivity/Allergic reaction (1907); Osteolysis (2377); No Code Available (3191)

Event Date 06/15/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).No 510(k) number provided because this implant is sold internationally with different indications for use; it is currently sold in the us under a different part number. the correction/removal reporting number listed applies to the corresponding product code sold domestically.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Clinical event of prosthesis explantation and reimplantation for right hip arthroplasty (for local mobilization reaction of metal-metal arthroplasty).Underwent primary right hip arthroplasty on date (b)(6) 2006 in other hospital (arthroplasty with acetabular implant asr depuy/ stem fin bioimplants).The patient was hospitalized on (b)(6) 2020 for an extensive periacetabular lysis, implant mobilization and for the presence of the periarticular pseudotumor with the need of the revision surgery detected to radiography.He underwent arteriography embolization for pseudo tumor mass on (b)(6) 2020.On date (b)(6) 2020 he underwent implant revision surgery: the stem was explanted and replaced with lima revision modular stem and revision of acetabular component with morcellised homologous bone and lima tt revision with screws.

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-001226.Ongoing post market surveillance is conducted per our procedures for this product.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.Added: a2 (dob), e1.Corrected: g1 (physical manufacturer), h5.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: ASR ACETABULAR IMPLANT 56
• Type of Device: ASR HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 10269143
• MDR Text Key: 199305935
• Report Number: 1818910-2020-15737
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 07/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 999804956
• Device Lot Number: 2203873
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Treatment: ASR ACETABULAR IMPLANT 56; DEPUY ASR XL FEM IMP SIZE 49; FIN STEM BIOIMPLANTS; LARGE MOD HEAD ADAPT 12/14 +5
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR