MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DISCOVERY ELBOW; DISC HUM 6X150MM LT FLANGED C

Catalog Number 114918

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 06/28/2018

Event Type  Injury  

Event Description

Revision surgery - due to the humeral stem being loose.

Manufacturer Narrative

The reason for this revision surgery was due to a loose stem.The actual length of in-vivo for the item listed is unknown as the original surgery date was not provided or could be established.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 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.A review of the device history records (dhr) was not conducted since the item and or lot number was not provided or determined during the complaint evaluation.Customer complaint history of the reported device showed no present trends or on-going issues that are in need of review.As of (b)(6) 2018, the records needed have not been forwarded by zimmer-biomet.Should zimmer-biomet provide the needed records at a later time, this investigation shall be updated.The root cause of this complaint was a revision surgery due to loose stem.Inventory containment is not required since there are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: DISCOVERY ELBOW
• Type of Device: DISC HUM 6X150MM 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: 7687373
• MDR Text Key: 114001681
• Report Number: 1644408-2018-00650
• Device Sequence Number: 1
• Product Code: JDC
• UDI-Device Identifier: 00888912225588
• UDI-Public: (01)00888912225588
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/18/2018

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 Catalogue Number: 114918
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/28/2018
• Initial Date FDA Received: 07/13/2018
• Supplement Dates Manufacturer Received: 07/17/2018
• Supplement Dates FDA Received: 07/18/2018
• 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
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 48 YR