MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 FCS CERAMIC 54 OR 56X28; HIP ACETABULAR INSERT/LINER

Catalog Number 159963054

Device Problem Insufficient Information (3190)

Patient Problem Foreign Body Reaction (1868)

Event Date 08/15/2011

Event Type  Injury  

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.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 patient was revised because of a fractured ceramic head.Injuries listed in the legal claim consisted of the effects of cobalt and chromium poisoning, including vision and hearing loss, thyroidism, cardiomyopathy, diabetes, pneumonia, fluid around the heart and extreme weight loss.

Manufacturer Narrative

Udi: unavailable.Depuy synthes has been informed that the catalog number and lot number is not available.Conclusion and justification status: the complaint states the patient underwent revision surgery to his right sided hip replacement.It was noted that the ceramic ball had cracked.The metal stem was replaced a review of manufacturing records and complaints databases did not identify any anomalies.The initial review of the information made available to the investigation found the product was to specification at the time of manufacturing.This information has been sent for further investigation to the ceramic supplier.The supplier will carry out further in-depth analysis to assist in the determination of the root cause.The investigation shall be closed with an interim report and be reopened when the suppliers report is completed.The investigation will be closed with an interim report and will be reopened when the ceramic supplier¿s report is completed.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.

Manufacturer Narrative

New etq record created in order to update etq (legacy system) complaint number dint (b)(4) with an update of the products involved.Reason for original complaint: received notification of this case via depuy leeds, on receipt of a notice of legal claim sent by the patient¿s lawyers ¿ letter dated (b)(4) 2012.The information below has been extracted from the "notice of claim¿ document.The primary surgery was performed by dr andrew graham at cairns private hospital.The patient underwent revision surgery to his right sided hip replacement.It was noted that the ceramic ball had cracked.The metal stem was replaced.Injuries listed in the claim consisted of the effects of cobalt and chromium poisoning, including vision and hearing loss, thyroidism, cardiomyopathy, diabetes, pneumonia, fluid around the heart and extreme weight loss.Additional information received from norton rose on (b)(4) 2014: primary right total hip replacement was performed on (b)(4) 2001 by (b)(4) at (b)(4) hospital (b)(4).1st revision surgery was performed on (b)(4) 2005 by (b)(4) at (b)(4) private hospital.Cup, liner and head removed.Fractured ceramic head (washout performed).The patient underwent a 2nd revision on (b)(4) 2011 ¿ captured in case (b)(4) com (b)(4) on (b)(4) 2015 message from australia:the dint result was not updated with product details and information.Please could you update the report to reflect the information provided and ask the investigators whether this information will change or add to the initial findings, as we are now overdue in reporting the findings to the tga.Could you please also emphasise the urgency of this request to the investigators as we will need to respond to the tga by the beginning of next week.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.

• Brand Name: FCS CERAMIC 54 OR 56X28
• Type of Device: HIP ACETABULAR INSERT/LINER
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer (Section G): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 5204778
• MDR Text Key: 30521819
• Report Number: 1818910-2015-34310
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/13/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 159963054
• Device Lot Number: YCD98
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/04/2017
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR