MAUDE Adverse Event Report: DEPUY INTL.,LTD 8010379 UNIDENTIFIED ASR TAPER SLEEVE; HIP OTHER IMPLANT

Catalog Number UNK-ASR

Device Problems Corroded (1131); Metal Shedding Debris (1804); Appropriate Term/Code Not Available (3191)

Patient Problems Cyst(s) (1800); Foreign Body Reaction (1868); Pain (1994); Discomfort (2330); No Code Available (3191)

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.This complaint is the subject of litigation or a legal claim and currently complete product detail is not available at this time.A follow-up medwatch will be filed as appropriate.

Event Description

New etq record created in order to update etq (legal system) complaint number (b)(4).Reason for original complaint - litigation papers allege on or about (b)(6) 2008 to present, patient suffered the following personal and economic injuries as a result of the implantation with the asr hip implant: pain and discomfort in his left hip causing potential unnecessary and additional surgeries, diminution in earning capacity, lost wages, medical monitoring expenses, emotional distress, loss of enjoyment of life, metallosis exposure and other injuries presently undiagnosed.It is also alleged the patient could not have known that he was injured by excessive levels of chromium and cobalt until after the date he had his blood drawn and he was advised of the results of said blood-work.Patient has not yet scheduled an explantation of the asr hip implant.Update: (b)(6) 2015 - transfer (b)(4).Patient was revised to address metal on metal asr hip.Update (b)(6) 2016 medical records received.Medical records reviewed for mdr reportability.Revision surgical report noted 500ml blood loss, trunnionosis, soft tissue staining, metallosis cysts, corrosion and metal debris.An unknown taper sleeve and stem are being added to the complaint for allegation of elevated ions without lab results and corrosion/trunnionosis.

Manufacturer Narrative

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, as there is an ongoing investigation regarding the root cause(s) and/or corrective actions.Ref.(b)(4).Depuy considers the investigation closed at this time.Should the product and/or additional information be received, the investigation will be re-opened.

• Brand Name: UNIDENTIFIED ASR TAPER SLEEVE
• Type of Device: HIP OTHER IMPLANT
• Manufacturer (Section D): DEPUY INTL.,LTD 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer (Section G): DEPUY INTL.,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: 5643758
• MDR Text Key: 44831724
• Report Number: 1818910-2016-19000
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK040627
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Attorney
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 04/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK-ASR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/11/2016
• 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
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 47 YR