MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. UNKNOWN DEPUY ASR FEMORAL HEAD SIZE 49; HIP FEMORAL HEAD

Catalog Number UNK-ASR

Device Problem Insufficient Information (3190)

Patient Problems Host-Tissue Reaction (1297); Foreign Body Reaction (1868); Pain (1994); Deformity/ Disfigurement (2360); Disability (2371); No Code Available (3191)

Event Date 01/21/2014

Event Type  Injury  

Event Description

Sales rep reported revision surgery.Patient has been revised to address pain.

Event Description

Update rec¿d (b)(6) 2014 - medical records received.Doi provided.Patient revised to address disability, fluid collection, synovitis and elevated metal ion levels.Upon revision, metallosis, debris, and trunnionosis were noted.The stem and sleeve are being added to the complaint.The stem remained in situ.This complaint was updated on: (b)(6) 2014.

Manufacturer 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.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.

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 02/18/2015- litigation papers received.Litigation alleges pain, metal poisoning, metallosis, metal debris, disability, physical impairment, disfigurment, and bodily injury.There is no new additional information that would affect the investigation.The complaint was updated on: 02/26/2015.

• Brand Name: UNKNOWN DEPUY ASR FEMORAL HEAD SIZE 49
• Type of Device: HIP FEMORAL HEAD
• 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: steve dowell ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743714918
• MDR Report Key: 3598345
• MDR Text Key: 4169527
• Report Number: 1818910-2014-11796
• 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
• Report Date: 02/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: UNK-ASR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2015
• 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): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 105