MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DISCOVERY ELBOW; DISC HUM 4X100MM RT FLANGED C

Catalog Number 114905

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

Patient Problem Insufficient Information (4580)

Event Date 04/05/2022

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 loosening of the humerus.

Manufacturer Narrative

The reason for this revision surgery was reported as loosening of the humerus.The previous surgery and the surgery detailed in this event occurred 11.2 months apart.The healthcare professional indicated this evaluation is limited in scope as the item(s) associated with this investigation was not returned to djo surgical for examination.The surgery was completed as intended and without incident.If additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.The devices were disposed of at hospital and not made available to djo surgical for examination.For item: 114905 - the device history record (dhr) was not found among djo and available zimmer biomet records.For remaining items: a review of the device history records (dhr) show that the reported components used in the previous surgery, when released for use, met design and manufacturing requirements.There were no non-conforming material reports (ncmr) associated with the products that may have contributed to the reported event.The devices were verified to have gone through an acceptable sterilization process and were 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 loosening of the humerus.The findings did not lead to a firm conclusion since the needed records were not made available at the time of this investigation.If more information is received later, the complaint will be updated.The surgeon performed this procedure to remedy the patient's condition.No further action is deemed necessary.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 4X100MM RT 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: james mcmahon ; 9800 metric blvd; austin, tx 78758-5445
• MDR Report Key: 14160858
• MDR Text Key: 289676272
• Report Number: 1644408-2022-00512
• Device Sequence Number: 1
• Product Code: JDC
• 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: 04/28/2022

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: 114905
• Device Lot Number: 022010
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/05/2022
• Initial Date FDA Received: 04/20/2022
• Supplement Dates Manufacturer Received: 04/22/2022
• Supplement Dates FDA Received: 04/29/2022
• 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
• Treatment: 540-00-000 LOT 84163; 600-10-100 LOT 939E1D0040; 600-10-100 LOT 945E1D0041
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female