MAUDE Adverse Event Report: DEPUY INTL., LTD - 8010379 TOTAL ASR FEM IMP SIZE 43; FEMORAL HEAD

Catalog Number 999803643

Device Problems Metal Shedding Debris (1804); Insufficient Information (3190)

Patient Problems Foreign Body Reaction (1868); Muscle Weakness (1967); Pain (1994); No Information (3190); No Code Available (3191)

Event Date 07/19/2013

Event Type  Injury  

Event Description

Patient seeking legal action.

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.Wwcapa (b)(4).Depuy considers this investigation closed at this time.Should the product and/or additional information be received, the investigation will be re-opened.

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).Depuy still considers this investigation closed.

Event Description

Update rec'd 08/14/2014- litigation papers received.Litigation alleges pain, weakness, metallosis, and elevated metal ions.The dob was provided.There is no new additional information that would affect the investigation.The complaint was updated on: 08/27/2014.

Manufacturer Narrative

Depuy still 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.

Event Description

Update ; 9/26/2016 medical records received.After review of the medical records for mdr reportability, in addition to what was previously reported, the primary right hip asr resurfacing surgery was completed in indian.The revision surgery notes reported a loose femoral head secondary to fracture, avascular necrosis, the femoral bone collapsed.There was a slight leg length discrepancy prior to revision.Part/lot numbers provided.

• Brand Name: TOTAL ASR FEM IMP SIZE 43
• Type of Device: FEMORAL HEAD
• Manufacturer (Section D): DEPUY INTL., LTD - 8010379; st. anthony's rd.; leeds, leeds LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): DEPUY INTL., LTD - 8010379; st. anthony's rd.; leeds, leeds LS11 8DT; UK LS11 8DT
• Manufacturer Contact: stacey trick ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743714554
• MDR Report Key: 3579798
• MDR Text Key: 19971082
• Report Number: 1818910-2014-10581
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,other
• Reporter Occupation: Attorney
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 09/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 06/01/2011
• Device Catalogue Number: 999803643
• Device Lot Number: 2164017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/14/2014
• Initial Date FDA Received: 01/16/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/27/2014; 10/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2006
• 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): Required Intervention
• Patient Age: 63 YR