MAUDE Adverse Event Report: ZIMMER BIOMET, INC. EXPLOR 7X26MM IMPL STEM W/SCR; PROSTHESIS, ELBOW

Catalog Number 11-210062

Device Problems Detachment of Device or Device Component (2907); Material Deformation (2976); Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)

Patient Problem No Information (3190)

Event Date 08/24/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: explor 14x20mm implant head cat# 11-210024 lot# 751940.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 03395.

Event Description

It was reported that the patient underwent an elbow procedure on an unknown date.Subsequently, patient underwent a revision as the set screw backed out from the head and stem.The head and screw disassociated from the stem and the screw floated in the patient's arm.The surgeon indicated that the screw appeared to be stripped.Further, the patient had osteopenic bone; therefore, the stem was loose and was removed.Patient was stable in flexion and extension so the surgeon decided to keep all devices out and close the patient.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Visual examination of the returned product identified item and lot numbers were hard to read unless you turn it the right way in the light.Inspection of each part found them to be damaged such as deformation, nicks, gouges and scratch marks.Review of the device history record(s) identified no deviations or anomalies during manufacturing.The screw backing out likely led to the disassociation; however, a definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information is available at the time of this report.

• Brand Name: EXPLOR 7X26MM IMPL STEM W/SCR
• Type of Device: PROSTHESIS, ELBOW
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10522174
• MDR Text Key: 206544269
• Report Number: 0001825034-2020-03394
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• PMA/PMN Number: K051385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Catalogue Number: 11-210062
• Device Lot Number: 975360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention