MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 DEPUY ASR XL FEM IMP SIZE 46; ASR HIP SYSTEM : HIP METAL FEMORAL HEADS

Catalog Number 999890146

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Injury (2348); No Code Available (3191)

Event Date 04/19/2016

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.Recall: z-1749/1816-2011.

Event Description

Asr claim.Patient male.The right hip of patient received thr in (b)(6) hospital on (b)(6) 2009; depuy asr¿ xl acetabular systems were implanted.Reportedly patient had been suffering painful for three years.According to recommendation of surgeon the revision surgery was applied on (b)(6) 2016 in the same hospital.The brand name of products used in the revision surgery is pinnacle and details as below: head ref: 1366-36-730, lot:7928606.Acetabular ref:1217-32-054, lot 713963.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.

• Brand Name: DEPUY ASR XL FEM IMP SIZE 46
• 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: 8025598
• MDR Text Key: 125701338
• Report Number: 1818910-2018-74081
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 999890146
• Device Lot Number: 2890575
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR