MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 DEPUY ASR XL FEM IMP SIZE 47; ASR HIP SYSTEM : HIP METAL FEMORAL HEADS

Catalog Number 999890147

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Pain (1994); No Code Available (3191)

Event Date 11/05/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Occupation: lawyer.Follow-up is being conducted to determine the contact information for the initial reporter.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

Asr index/revision procedure.Asr resurfacing.Right hip.Reason(s) for revision: pain.Doi: (b)(6) 2005 - dor: (b)(6) 2020 (right hip).

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.H10 additional narrative: added: a2 (date of birth), a3 and d6b.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: a1.

• Brand Name: DEPUY ASR XL FEM IMP SIZE 47
• Type of Device: ASR HIP SYSTEM : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 10479441
• MDR Text Key: 205267345
• Report Number: 1818910-2020-19209
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 08/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 999890147
• Device Lot Number: 2043825
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Treatment: CORAIL2 STD SIZE 12; DEPUY ASR XL FEM IMP SIZE 47; UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP FEMORAL AUGMENT
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR