MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. UNKNOWN REPLICA 12MM, HEAD 28MM+6MM; HIP FEMORAL HEAD

Model Number 152190060

Device Problem Disassembly (1168)

Patient Problem Foreign Body Reaction (1868)

Event Date 10/17/2014

Event Type  Injury  

Event Description

A revision was performed on (b)(6) in 2014 due to armd.The initial tha surgery was performed in 2004, and the head was revised in 2013 at another hospital due to recurrent dislocation.However, the patient was admitted to the hospital on suspicion of infection.Although the surgeon found disassociation between the head and the stem, it was unable to identify any pathogen associated with infections.There was also no sign of leukocytosis despite an increase in the crp.Thus, the surgeon eventually concluded that the patient had been suffering from armd and performed the complete removal of the implants.The surgeon believes that the patient's joint was already loose from last year due to loss of soft tissues such as gluteal muscle because of amrd.Implants information: replica 12mm, head 28mm+6mm (changed last year).Duraloc 1200 52mm, liner 52mm.During the surgery, necrosis (whitening) that might be ascribed to metal debris was found around the soft tissues (scar tissues) and the femur proximal area.The minimus gluteus muscle was found lost and medius gluteus muscle was also found largely lost.The synovial fluid was white.The surgeon requested sem analysis of the head neck junction.There was a surgical delay that took 2 hours for the removal.The patient is now under observation for a full recovery.

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.(b)(4).

Manufacturer Narrative

(b)(4).This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.

Manufacturer Narrative

Part/lot received.This product is not sold in the u.S.Depuy considers this investigation closed at this time.

• Brand Name: UNKNOWN REPLICA 12MM, HEAD 28MM+6MM
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: steve dowell ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743714918
• MDR Report Key: 4242822
• MDR Text Key: 4991090
• Report Number: 1818910-2014-31539
• 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: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 152190060
• Device Catalogue Number: UNK-HIP
• Device Lot Number: D13051917
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2015
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR