MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. KERAMOS HIP; CUP, AL-AL FLRD RIM 52MM

Catalog Number 498-00-052

Device Problems Break (1069); Positioning Problem (3009)

Patient Problems Device Embedded In Tissue or Plaque (3165); No Code Available (3191)

Event Date 07/11/2014

Event Type  Injury  

Event Description

Revision surgery - due to the patient's cup being mal-positioned and the ceramic liner shattering.The cup was showing to be too vertical which caused the liner to shatter.

Manufacturer Narrative

The reason for this revision surgery was identified as cup mal-positioned and liner shattered after 12.3 years of patient use.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 device history records showed no non-conforming material reports associated with this product.A review of the product complaint report history showed there are (b)(4) prior complaints on part number 498-32-052.Of these (b)(4) complaints, (b)(4) complaints were for infection and pain, (b)(4) complaints for device cracked/broke and rest of the complaints were for poor joint.A root cause for this event could be attributed to such factors as trauma, excessive weight bearing activities, edge loading, excessive physical activity, and insufficient joint tension leading to increased impact loading or mal-position of cup which could expose the bone screw head and lead to impingement with the liner causing liner to shatter.There is no information reported that showed a material, design, or manufacturing problem with the product.

• Brand Name: KERAMOS HIP
• Type of Device: CUP, AL-AL FLRD RIM 52MM
• 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: 3937799
• MDR Text Key: 22142390
• Report Number: 1644408-2014-00451
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: D980003/S4
• 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: 07/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2006
• Device Catalogue Number: 498-00-052
• Device Lot Number: 736881
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/12/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2001
• 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: 010-55-035,LOT 618911; 010-55-025,LOT 757501; 400-01-296,LOT 775871; 498-32-052,LOT 736881
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR