MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DISCOVERY ELBOW; DISC HUM 5X100MM LT FLANGED C

Catalog Number 114906

Device Problems Appropriate Term/Code Not Available (3191); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Date 06/04/2019

Event Type  Injury  

Event Description

Revision surgery - due to loose humeral stem, surgeon put spacer in due to high white cell count.Need to be lower until revision implants can be placed.

Manufacturer Narrative

The reason for this revision surgery was reported as an loose stem.The previous surgery and the revision detailed in this investigation occurred 1.6 years apart.The healthcare professional indicated there was a significant adverse event to the patient.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 the hospital and not made available to djo surgical for examination.A review of the implant device history records (dhr) show that the reported component used in the previous surgery met design and manufacturing requirements.There were no non-conforming material reports (ncmr) associated with the product that may have contributed to the reported event.For item : 114906 - a review of the implant dhr could not be conducted as the records are not available.Because of the acquisition by djo surgical, an extended search of zimmer biomet records cannot be conducted.Any records before the acquisition date, that have not been forwarded, will not be made available.Customer complaint history of the reported device showed no present trends or on-going issues that are in need of review.The device was within its expiration date at the time of the previous surgery.The root cause of this complaint was a revision surgery due to loose stem.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 of the control of djo surgical.There are no indications of a product or process issue affecting implant safety or effectiveness.

Manufacturer Narrative

D10 - adding concomitant part 402439.

• Brand Name: DISCOVERY ELBOW
• Type of Device: DISC HUM 5X100MM LT FLANGED C
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445 TX 78758 5445
• Manufacturer (Section G): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445 TX 78758 5445
• Manufacturer Contact: teffany hutto ; 9800 metric blvd; austin, tx 78758-5445, TX 78758-5445
• MDR Report Key: 8760128
• MDR Text Key: 150025935
• Report Number: 1644408-2019-00627
• 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,Followup
• Report Date: 05/27/2022

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: 114906
• Device Lot Number: 282390
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/04/2019
• Initial Date FDA Received: 07/03/2019
• Supplement Dates Manufacturer Received: 07/25/2019; 07/25/2019
• Supplement Dates FDA Received: 08/23/2019; 05/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2017
• 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: 114700. LOT 201750; 114812. LOT 520280; 114993. LOT 250610; 114993. LOT 946730; 402439 COBALT-G MV BONE CEMENT 40GM B; 114700. LOT 201750; 114812. LOT 520280; 114993. LOT 250610; 114993. LOT 946730
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 67 YR
• Patient Sex: Female