MAUDE Adverse Event Report: ENCORE MEDICAL L.P. KERAMOS HIP; LINER, CERAMIC ,AL-AL 28X56/58MM

Catalog Number 498-28-056

Device Problem Unstable (1667)

Patient Problem No Code Available (3191)

Event Date 02/26/2018

Event Type  Injury  

Event Description

Revision surgery - due to the patient having laxity due to an anterverted stem.The surgeon wanted to replace the liner since it was disrupted while replacing the stem.

Manufacturer Narrative

The reason for this revision surgery was due to an anterverted stem causing laxity.The previous surgery and the revision detailed in this investigation occurred 14.2 years apart.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.There are no reported pre-existing patient health conditions.The healthcare professional indicated there was a significant adverse event to the patient.There was no delay in surgery and another suitable device was available for use.The revision surgery was completed as intended.The device was not made available to djo surgical for examination.A review of the implant device history records (dhrs) show that the reported component used in the previous surgery met design and manufacturing requirements.There were no non-conforming material reports (ncmrs) associated with the product that may have contributed to this event.Customer complaint history of the reported device showed no present trends or on-going issues that are in need of review.The device was verified to have gone through an acceptable sterilization process and was within it's expiration date at the time of use during the previous surgery.The root cause of this complaint was a revision surgery due to anterverted stem causing laxity.There were no findings during this investigation that indicate that the reported device was defective.There are multiple factors that may contribute to an event that are outside of the control of djo surgical.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: KERAMOS HIP
• Type of Device: LINER, CERAMIC ,AL-AL 28X56/58MM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• Manufacturer (Section G): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• Manufacturer Contact: teffany hutto ; 9800 metric blvd; austin, TX 78758-5445
• MDR Report Key: 7318490
• MDR Text Key: 101663195
• Report Number: 1644408-2018-00190
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 00888912087568
• UDI-Public: (01)00888912087568
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: D980003
• 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: 03/29/2018

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: 04/28/2008
• Device Catalogue Number: 498-28-056
• Device Lot Number: 889731
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/26/2018
• Initial Date FDA Received: 03/06/2018
• Supplement Dates Manufacturer Received: 03/28/2018
• Supplement Dates FDA Received: 03/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2003
• 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): Other; Required Intervention
• Patient Age: 62 YR