MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DISCOVERY ELBOW; DISC ULNA 3X115MM LT W BRNG C

Catalog Number 114816

Device Problem Fracture (1260)

Patient Problem No Code Available (3191)

Event Date 03/06/2018

Event Type  Injury  

Event Description

Revision surgery - received an email from zimmer biomet on (b)(6) 2018, stating that, "it was reported that the patient underwent an initial left total elbow procedure on (b)(6) 2010.Subsequently, the patient was revised due to implant fracture on (b)(6) 2018.

Manufacturer Narrative

Manufacturer narrative: the reason for this revision surgery was due to an implant fracture.The previous surgery and the revision detailed in this investigation occurred 7.6 years apart.There is no information in this complaint about any patient injuries, activities, or accidents that may have contributed to the need for this revision surgery.There are no reported pre-existing patient health conditions.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 device was not made available to djo surgical for examination.A review of the implant device history records (dhr), shows that the reported component used in the previous surgery met design and manufacturing requirements.There were no non-conforming material reports (ncmrs) associated with the product that may have contributed to the reported event.As of 4-may-2018, the records needed, to verify an acceptable sterilization process, have not been forwarded by zimmer-biomet.Should zimmer-biomet provide the needed records at a later time, this investigation shall be updated.Customer complaint history of the reported device showed no present trends or on-going issues that are in need of review.The root cause of this complaint was a revision surgery due to implant fracture.There were no findings during this investigation that indicate that the reported device was defective.There are multiple factors that may contribute to an event that are outside of the control of djo surgical.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.

Manufacturer Narrative

Manufacturer narrative: the reason for this revision surgery was due to an implant fracture.The previous surgery and the revision detailed in this investigation occurred 7.6 years apart.There is no information in this complaint about any patient injuries, activities, or accidents that may have contributed to the need for this revision surgery.There are no reported pre-existing patient health conditions.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 device was not made available to djo surgical for examination.A review of the implant device history records (dhr), shows that the reported component used in the previous surgery met design and manufacturing requirements.There were no non-conforming material reports (ncmrs) associated with the product that may have contributed to the reported event.As of 4-may-2018, the records needed, to verify an acceptable sterilization process, have not been forwarded by zimmer-biomet.Should zimmer-biomet provide the needed records at a later time, this investigation shall be updated.Customer complaint history of the reported device showed no present trends or on-going issues that are in need of review.The root cause of this complaint was a revision surgery due to implant fracture.There were no findings during this investigation that indicate that the reported device was defective.There are multiple factors that may contribute to an event that are outside of the control of djo surgical.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.

Manufacturer Narrative

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 ULNA 3X115MM LT W BRNG 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: teffany hutto ; 9800 metric blvd; austin, TX 78758-5445
• MDR Report Key: 7408212
• MDR Text Key: 104730423
• Report Number: 1644408-2018-00305
• Device Sequence Number: 1
• Product Code: JDC
• UDI-Device Identifier: 00888912225168
• UDI-Public: (01)00888912225168
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2015
• Device Catalogue Number: 114816
• Device Lot Number: 332520
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2010
• 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 082120.; 114906 LOT 836600.; 402283 LOT 504960.; 402283 LOT 504960.; 414991 LOT 715060.
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male