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

Catalog Number 114906

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Unspecified Infection (1930); Discomfort (2330)

Event Date 09/22/2017

Event Type  Injury  

Event Description

Revision surgery - due to elbow discomfort and the components becoming loose, likely due to an infection.

Manufacturer Narrative

The reason for this revision surgery was loosening of the components and infection.The previous surgery and the revision detailed in this investigation occurred 4.8 years apart.No information was submitted with the complaint regarding pre-existing conditions of the patient or any activities the patient was involved in that may have contributed to the infection or inhibited the patient's immune system.The healthcare professional indicated there was a serious risk 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 disposed of at the hospital and not made available to djo surgical for examination.An attempt to zimmer-biomet has been made to obtain the previous invoices needed to confirm the explanted devices and verify the date of the previous surgery.Along with the invoices the device history records and sterility certificates were also requested.As of (b)(4) 2017 the requested records have not been made available.Should zimmer-biomet provide the requested records at a later time, this investigation shall be re-evaluated.Since the acquisition of zimmer-biomet, customer complaint history of the reported device(s) 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 infection/component loosening.No information was submitted with the complaint regarding pre-existing conditions of the patient or any activities the patient was involved in that may have contributed to the infection or inhibited the patient's immune system.There are multiple factors that may contribute to an infection 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 LT FLANGED C
• 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: 6961730
• MDR Text Key: 89726460
• Report Number: 1644408-2017-00910
• Device Sequence Number: 1
• Product Code: JDC
• UDI-Device Identifier: 00888912225489
• UDI-Public: (01)00888912225489
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K013042
• 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: 12/18/2017

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 Catalogue Number: 114906
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/22/2017
• Initial Date FDA Received: 10/19/2017
• Supplement Dates Manufacturer Received: 12/12/2017
• Supplement Dates FDA Received: 12/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 114700; 114813
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 65 YR