MAUDE Adverse Event Report: DEPUY INTL., LTD - 8010379 DEPUY ASR XL FEM IMP SIZE 57; HIP FEMORAL HEAD

Catalog Number 999890157

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

Patient Problems Foreign Body Reaction (1868); Muscle Weakness (1967); Pain (1994); Discomfort (2330); No Code Available (3191)

Event Date 04/04/2014

Event Type  Injury  

Event Description

Sales rep reported revision surgery.Patient has been revised to address elevated metal ion levels.

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.(b)(4).Depuy still considers this investigation closed.

Event Description

Update rec'd 7/1/2014 - litigation received.Litigation alleges pain, stiffness, discomfort, and weakness.There is no new additional information that would affect the investigation.This complaint was updated on: 07/14/2014.

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 07/25/2014 - plaintiff's preliminary disclosure form was received, which identified dob 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: 07/30/2014.

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 7/28/2014 - medical records received.Patient revised to address metallosis.Upon revision, copious amounts of metal staining fluid, metal debris, and no osseointegration into the acetabular cup were noted.The information received does not change the mdr decision.This complaint was updated on: 07/31/2014.

• Brand Name: DEPUY ASR XL FEM IMP SIZE 57
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY INTL., LTD - 8010379; st. anthony's rd; leeds LS11 8 D; UK LS11 8 DT
• Manufacturer (Section G): DEPUY INTL., LTD - 8010379; 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: 3768766
• MDR Text Key: 4552265
• Report Number: 1818910-2014-17385
• 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,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/28/2014

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: 999890157
• Device Lot Number: 2611857
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/28/2014
• Initial Date FDA Received: 04/23/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 07/15/2014; 07/30/2014; 07/31/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2008
• 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: 56 YR
• Patient Weight: 154