MAUDE Adverse Event Report: DEPUY INTL.,LTD 8010379 UNKNOWN DEPUY ASR ACETABULAR CUP; HIP ACETABULAR CUP

Catalog Number UNK-ASR

Device Problems Nonstandard Device (1420); Osseointegration Problem (3003); Appropriate Term/Code Not Available (3191)

Patient Problems Host-Tissue Reaction (1297); Pain (1994); Scar Tissue (2060); Weakness (2145); Inadequate Osseointegration (2646); No Information (3190); No Code Available (3191)

Event Date 03/23/2017

Event Type  Injury  

Manufacturer Narrative

Complete product detail has not been received at this time.If further information is received a follow-up medwatch will be filed as appropriate.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Aug 8, 2017: litigation records received.Litgation alleges high concentrations of various metallic elements in the patient's blood.

Manufacturer Narrative

No device associated with this report was received for examination.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.

Manufacturer Narrative

Litigation records received.Litigation alleges high concentrations of various metallic elements in the patient's blood.The reported event has been evaluated and will be monitored.Depuy considers the investigation closed at this time.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.

Event Description

After review of medical record, it was stated that the patient was revised to address metallosis and aseptic loosening of the acetabular component.Pain, weakness and disability were also noted.Revision notes reported that a scar tissues were removed and there was no bone ingrowth in the porous coating of the shell.Doi: (b)(6) 2009 - (b)(6) 2017 (right hip).

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.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.Product complaint # (b)(4).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.Device history lot = null.Device history batch = null.Device history review = null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN DEPUY ASR ACETABULAR CUP
• Type of Device: HIP ACETABULAR CUP
• Manufacturer (Section D): DEPUY INTL.,LTD 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• MDR Report Key: 6849404
• MDR Text Key: 85157083
• Report Number: 1818910-2017-24182
• Device Sequence Number: 0
• Product Code: OVO
• PMA/PMN Number: K040627
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/10/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK-ASR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR