MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. DEPUY ASR FEM IMPLANT SZ 49; HIP FEMORAL STEM/SLEEVE

Catalog Number 999890049

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Injury (2348); Disability (2371); No Code Available (3191)

Event Date 12/19/2013

Event Type  Injury  

Event Description

Litigation alleges pain, disability, impairment, loss of function, use and range of motion, decreased and poor hip performance and longevity, gait disturbance, metallic and other particulate contamination of the blood, elevated metal ion levels, internal scarring, and irritation and injury to the tendons, ligaments, muscles, blood vessels, cartilages, nerves, bones and soft tissues of the hip joint and surrounding areas.

Manufacturer Narrative

Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.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.(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.Depuy still considers this investigation closed.

Event Description

Update rec'd 08/22/2014 - plaintiff's fact sheet was received, which identified dor information.The complaint and associated mdrs were updated.There was no new information that would change the outcome of the investigation.The complaint was updated on: 09/03/2014.

• Brand Name: DEPUY ASR FEM IMPLANT SZ 49
• Type of Device: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD.; st. anthony's rd; leeds LS11 8 D; UK LS11 8 DT
• Manufacturer (Section G): DEPUY INTERNATIONAL LTD.; st. anthony's rd; leeds LS11 8 D; UK LS11 8 DT
• Manufacturer Contact: stacey trick ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743714554
• MDR Report Key: 3595896
• MDR Text Key: 4167915
• Report Number: 1818910-2014-11688
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK032659
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Attorney
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 08/22/2014

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 Catalogue Number: 999890049
• Device Lot Number: 2756883
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/22/2014
• Initial Date FDA Received: 01/28/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2009
• 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: 51 YR