MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DISCOVERY ELBOW; DISC HUM 5X100MM RT FLANGED C

Catalog Number 114907

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Date 08/15/2018

Event Type  Injury  

Event Description

Revision surgery - due to the patient beginning to loosen.

Manufacturer Narrative

Manufacturer narrative: the reason for this revision surgery was due to loosening.The previous surgery and the surgery detailed in this investigation occurred 8.7 months 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 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.As of 26-sep-2018, no device history records (dhr) and the records needed to verify an acceptable sterilization process have been forwarded by zimmer-biomet concerning the items listed in this complaint, therefore a review could not be performed.Should zimmer-biomet provide the records needed for review, the complaint will be re-opened and a further review shall be conducted.Customer complaint history of the reported device showed no present trends or on-going issues that are in need of review.The root cause of this complaint was a revision surgery due to loosening.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: DISCOVERY ELBOW
• Type of Device: DISC HUM 5X100MM RT FLANGED C
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 7819694
• MDR Text Key: 118329179
• Report Number: 1644408-2018-00798
• Device Sequence Number: 1
• Product Code: JDC
• UDI-Device Identifier: 00888912224833
• UDI-Public: (01)00888912224833
• Combination Product (y/n): N
• PMA/PMN Number: K013042
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 114907
• Device Lot Number: 823000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 114700, LOT 427820; 114907, LOT 823000; 114907, LOT 823000
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR