MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DISCOVERY ELBOW; UKNOWN

Catalog Number UKNOWN

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Code Available (3191)

Event Date 01/03/2019

Event Type  Injury  

Event Description

Revision surgery - due to the humeral component loosening.

Manufacturer Narrative

Corrected data: common device name changed to unknown.Manufacturer narrative: the reason for this revision surgery was due to loose component.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.This complaint evaluation is limited in scope since the part(s) associated with this investigation was not returned to djo surgical for evaluation.A review of the device history records (dhr) was not conducted since the item and or lot number(s) was not provided or determined during the complaint evaluation.Given the limited information, a search for an invoice of the previous surgery produced no results.As of 7 feb 2019, 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 component.This complaint will be closed with the item and or lot number(s) unknown pending receipt of additional information.No further action is deemed necessary.

• Brand Name: DISCOVERY ELBOW
• Type of Device: UKNOWN
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 8267510
• MDR Text Key: 133746993
• Report Number: 1644408-2019-00052
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• PMA/PMN Number: K051975
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/22/2019

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: UKNOWN
• Device Lot Number: UKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/03/2019
• Initial Date FDA Received: 01/22/2019
• Supplement Dates Manufacturer Received: 02/07/2019
• Supplement Dates FDA Received: 02/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR