MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DISCOVERY ELBOW; DISC ULNA 2.5X53MM LT BOND CT

Catalog Number 114802

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

Patient Problem Pain (1994)

Event Date 09/23/2020

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 - patient presented to surgeon with pain in left elbow.Upon further review and x-rays, surgeon thought the ulnar component in total elbow was loose and decided to take patient to surgery.Once left elbow was opened, the ulnar implant was indeed loose and removed.The 2 implants removed and replaced in the revision surgery are inventoried.

Manufacturer Narrative

Corrected data: see d.1., d.2., d.4.& d.10.Manufacturer narrative: the reason for this revision surgery was reported as loosening.The previous surgery and the surgery detailed in this event occurred 2.5 years apart.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 devices were disposed of at hospital and not made available to djo surgical for examination.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 pain from loose component.There were no findings during the 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 implants safety or effectiveness.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

Manufacturer Narrative

Corrected data: manufacturer narrative: the reason for this revision surgery was reported as loosening.The previous surgery and the surgery detailed in this event occurred 2.7 years apart.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 devices were disposed of at hospital and not made available to djo surgical for examination.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.There were no findings during the 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 implants safety or effectiveness.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

Event Description

Second revision surgery - patient presented to surgeon with pain in her left elbow.Upon further review and x-rays, surgeon thought the ulnar component in her total elbow was loose and decided to take her to surgery.Once her left elbow was opened the ulnar implant was indeed loose and removed.The 2 implants removed and replaced in the revision surgery are inventoried above.

Manufacturer Narrative

Corrected data: b5: event described as second revision surgery in error.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

Event Description

Revision surgery: patient presented to surgeon with pain in her left elbow.Upon further review and x-rays, surgeon thought the ulnar component in her total elbow was loose and decided to take her to surgery.Once her left elbow was opened the ulnar implant was indeed loose and removed.The 2 implants removed and replaced in the revision surgery are inventoried above.

• Brand Name: DISCOVERY ELBOW
• Type of Device: DISC ULNA 2.5X53MM LT BOND CT
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445
• MDR Report Key: 10712787
• MDR Text Key: 212331434
• Report Number: 1644408-2020-00942
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• PMA/PMN Number: K090473
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/13/2021
• Device Catalogue Number: 114802
• Device Lot Number: 082910
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 114700 LOT 804560; 114802 LOT 082910; 114802 LOT 082910
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 80