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 Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/14/2019

Event Type  Injury  

Manufacturer Narrative

Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.

Event Description

Revision surgery - due to loosen of humeral component.

Manufacturer Narrative

Manufacturer narrative: the reason for this revision surgery was reported as loosening.The actual length of in-vivo for the items listed is unknown as the original surgery date was not provided or could be established.Invalid item numbers reported, effected items have been changed to reflect the year of the primary surgery which was before the acquisition of djo surgical.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 were disposed of at hospital and not made available to djo surgical for examination.The revised items was not returned for examination and the item and or lot numbers was not provided.To adequately investigate this event, the part and or lot numbers are necessary.If this information is submitted at a future date, this investigation will be re-evaluated.There was no information submitted with this complaint about any patient activities, accidents, or medical contraindications that may have contributed to the reported event.

• 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
• MDR Report Key: 9458867
• MDR Text Key: 170658341
• Report Number: 1644408-2019-01195
• Device Sequence Number: 1
• Product Code: JDC
• 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: 01/08/2020

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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/14/2019
• Initial Date FDA Received: 12/12/2019
• Supplement Dates Manufacturer Received: 12/13/2019
• Supplement Dates FDA Received: 01/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 114700 LOT UNKNOWN; 114800 LOT UNKNOWN; 540-00-000 LOT UNKNOWN; 540-01-001 LOT UNKNOWN
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR