MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. DISCOVERY ELBOW; DISC CONDYLE KIT WITH HEXALOBULA

Catalog Number 114700

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Code Available (3191)

Event Date 01/25/2016

Event Type  Injury  

Event Description

Revision surgery - due to the patient's implants being loose.

Manufacturer Narrative

The reason for this revision surgery was loosening.The length of the in-vivo service is unknown since the original surgery was not provided or determined.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 (dhrs) revealed no discrepancies or issues with the manufacturing history of this part.All parts were found to meet design and manufacturing specifications.No non-conforming material reports (ncmr's) were associated with this part.The product complaint report history was reviewed and no trends or on-going issues were deemed as present or in need of review.This event is deemed to be non-product related.The surgeon reported no issues associated with the explanted product and provided no information that definitively described the root cause or reason of the elbow looseness.The scope of this investigation is limited without having the parts available to djo surgical for evaluation.Factors that may contribute to joint instability that are not associated with the implants are: improper implant selection, degenerative bone disease, patient non-compliance with medical instructions.Other conditions relating to this event could not be determined with confidence.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: DISCOVERY ELBOW
• Type of Device: DISC CONDYLE KIT WITH HEXALOBULA
• 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: 5458523
• MDR Text Key: 38963947
• Report Number: 1644408-2016-00068
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051975
• 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: 01/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: 114700
• Device Lot Number: 120920
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2013
• 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