MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. ALFA II HIP; STEM, HIP, ALFA II #7, MODULAR PC

Catalog Number 650-07-195

Device Problem Material Separation (1562)

Patient Problem No Code Available (3191)

Event Date 05/03/2016

Event Type  Injury  

Event Description

Revision surgery - due to the neck disassociating from the stem.The surgeon performed a revision of the stem, head and liner.

Manufacturer Narrative

The reason for this revision surgery was a dissociation of an alfa ii modular hip stem and the modular neck.The implants were in the patient for six years and two months prior to revision.There is no information in this complaint about any patient injuries, activities, or accidents that may have contributed to the need for this revision surgery.The healthcare professional indicated there was no delay in surgery and another suitable device was available for use.The revision surgery was completed as intended.The device was disposed of at the hospital and not made available to djo surgical for examination.A review of the devise history records revealed no non-conforming material reports (ncmrs) associated on this lot of 23 alfa ii stems.A review of the product complaint report history shows one prior complaint, (b)(4) against part number 650-07-195, where the implant was revised due to the stem sinking.The stem had no bony ingrowth.This complaint is not related to the current complaint.The current complaint is the first complaint for lot 2730a.This investigation is limited in scope because the explanted products were not returned to djo surgical and a definitive root cause cannot be determined.The root cause identified as the reason for revision was dissociation of the modular femoral neck from the modular stem.There was no information reported that evidences a material, design, or manufacturing problem with the explanted products.Factors that can contribute to dissociation include trauma, component positioning, prior revision surgery reducing the effectiveness of the neck connection, inadequate impaction force, and blood/fluid/debris on the taper surfaces prior to impaction.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: ALFA II HIP
• Type of Device: STEM, HIP, ALFA II #7, MODULAR PC
• Manufacturer (Section D): ENCORE MEDICAL, L.P.; 9800 metric blvd.; austin TX 78758
• Manufacturer (Section G): ENCORE MEDICAL, L.P.; 9800 metric blvd.; austin TX 78758
• Manufacturer Contact: teffany hutto ; 9800 metric blvd.; austin, TX 78758-5445 ; 5128346255
• MDR Report Key: 5694785
• MDR Text Key: 46402775
• Report Number: 1644408-2016-00331
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K000817
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/03/2016

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: Health Professional
• Device Expiration Date: 08/31/2012
• Device Catalogue Number: 650-07-195
• Device Lot Number: 2730A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/04/2016
• Initial Date FDA Received: 06/02/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2006
• 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
• Treatment: 499-34-008,LOT 284992
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR