MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DISCOVERY ELBOW; DISC HUM 5X150MM LT FLANGED C

Catalog Number 114916

Device Problems Fracture (1260); Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191)

Patient Problems Bone Fracture(s) (1870); No Known Impact Or Consequence To Patient (2692)

Event Date 02/12/2019

Event Type  Injury  

Event Description

Revision surgery - due to the patient fracturing their humerus, making implant loose.The surgeon replaced humeral stem and bearings during revision.

Manufacturer Narrative

The reason for this revision surgery was due to loosening.The previous surgery and the surgery detailed in this investigation occurred 1.3 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 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 implant device history records (dhr), shows that the reported component used in the previous surgery, when released for use, met design and manufacturing requirements.There were no non-conforming material reports (ncmrs) associated with the product that may have contributed to the reported event.The device was verified to have gone through an acceptable sterilization process and was within its expiration date at the time of use during the previous surgery.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 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: DISCOVERY ELBOW
• Type of Device: DISC HUM 5X150MM LT FLANGED C
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 8412935
• MDR Text Key: 138571251
• Report Number: 1644408-2019-00171
• Device Sequence Number: 1
• Product Code: JDC
• UDI-Device Identifier: 00888912225564
• UDI-Public: (01)00888912225564
• 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: 05/22/2019
• 2 Devices were Involved in the Event: 1 2

2 Patient was Involved in the Event

• Date FDA Received: 03/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 114916
• Device Lot Number: 708300
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 0
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 67 YR