MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DISCOVERY ELBOW; DISC HUM 4X200MM RT FLANGED C

Catalog Number 114925

Device Problems Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 12/02/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Revision surgery - revision right total elbow.Patient had humeral loosening.New humeral implant and condyle kit was used.

Manufacturer Narrative

Corrected data: manufacturer narrative: the reason for this revision surgery was reported as humeral loosening.The previous surgery and the surgery detailed in this event occurred 1.2 years apart.The healthcare professional indicated that there was no delay in surgery and another suitable device was available for use.The revision surgery was completed as intended.The devices were disposed of at the hospital and not made available to djo surgical for examination.For item: 114925 the device history record (dhr) was not found among djo and available zimmer biomet records.For the item 540-00-000 : a review of the implant device history record (dhr) shows that the reported component used in the previous surgery, when released for use, met design and manufacturing requirements.There was no nonconforming material report (ncmr) associated with the product that may have contributed to the reported event.The device was within its expiration date at the time of the previous surgery.Customer complaint history of the reported devices showed no present trends or on-going issues that are needing a review.The root cause of this complaint was a revision surgery due to humeral loosening.There were no findings during this evaluation that indicate the reported devices were defective.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 event.There are multiple factors that may contribute to an event that are outside the control of djo surgical.There are no indications of a product or process issue affecting implant safety or effectiveness.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

Manufacturer Narrative

Manufacturer narrative: the reason for this revision surgery was reported as humeral loosening.The previous surgery and the surgery detailed in this event occurred 1.2 years apart.The healthcare professional indicated that there was no delay in surgery and another suitable device was available for use.The revision surgery was completed as intended.The devices were disposed of at the hospital and not made available to djo surgical for examination for item: 114925: the device history record was not found among djo and available zimmer biomet records.For item: 540-00-000: a review of the implant device history record (dhr) shows that the reported component used in the previous surgery, when released for use, met design and manufacturing requirements.There were no non-conforming material report (ncmr) associated with the product that may have contributed to the reported event.The device was within its expiration date at the time of the previous surgery.Customer complaint history of the reported devices showed no present trends or on-going issues that are needing a review.The root cause of this complaint was a revision surgery due to humeral loosening.The findings did not lead to a firm conclusion since the needed records were not made available at the time of this investigation.If the records or additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.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 event.There are multiple factors that may contribute to an event that are outside the control of djo surgical.There are no indications of a product or process issue affecting implant safety or effectiveness.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

• Brand Name: DISCOVERY ELBOW
• Type of Device: DISC HUM 4X200MM RT FLANGED C
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445
• MDR Report Key: 11095546
• MDR Text Key: 224385013
• Report Number: 1644408-2020-01183
• 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,Followup
• Report Date: 07/26/2021

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: 114925
• Device Lot Number: 970970
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/02/2020
• Initial Date FDA Received: 12/30/2020
• Supplement Dates Manufacturer Received: 02/24/2021; 04/17/2021
• Supplement Dates FDA Received: 03/24/2021; 07/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 540-00-000 LOT 75736; 540-00-000 LOT 75736
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR