MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DISCOVERY ELBOW; DISC HUM 6X100MM RT FLANGED C

Catalog Number 114909

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/27/2020

Event Type  Injury  

Manufacturer Narrative

The reason for this revision surgery was reported as loosening.Initial implant done approximately 5 yrs prior.The actual length of in-vivo for the item listed is unknown as the original surgery date was not provided or could be established.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 hospital and not made available to djo surgical for examination.The revised item was not returned for examination and the lot number was not provided.To adequately investigate this event, the lot number was necessary.If this information is submitted at a future date, this investigation will be re-evaluated.The root cause of this complaint was a revision surgery due to loosening.There was no information submitted with this complaint about any patient activities, accidents, or medical contraindications that may have contributed to the reported event.This complaint will be closed pending receipt of additional information.

Event Description

Revision surgery - revision of humeral component due to loose component.Initial implant done approximately 5 years prior.

• Brand Name: DISCOVERY ELBOW
• Type of Device: DISC HUM 6X100MM RT FLANGED C
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445,
• MDR Report Key: 9750340
• MDR Text Key: 180832387
• Report Number: 1644408-2020-00107
• 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: 02/25/2020

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: 114909
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/28/2020
• Initial Date FDA Received: 02/25/2020
• Supplement Dates Manufacturer Received: 01/28/2020
• Supplement Dates FDA Received: 02/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR