MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VERSA-DIAL/COMP TI STD TAPER; PROSTHESIS, EXTREMITY

Model Number N/A

Device Problems Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)

Patient Problems Joint Dislocation (2374); Reaction (2414)

Event Date 06/27/2013

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr's were filed for this event.Please see: 0001825034-2018-05021, 0001825034-2018-05022, 0001825034-2018-05023, 0001825034-2019-02694.Concomitant medical products: catalog # 113648, comprehensive primary stem 8 mm std, lot # 104520.Catalog # 118001, versa-dial/comprehensive ti standard taper, lot # 201410.Catalog # xl-115363, arcom xl 44-36 standard humeral bearing, lot # 011140.Catalog # 115340, comprehensive reverse humeral ti tray 44 mm, lot # 492370.Catalog # 115330, comprehensive reverse shoulder baseplate, lot # 550050.Catalog # 180501, fixed locking screw, lot # 468580.No device was returned for examination.Medical records were reviewed and confirmed device disassociation and dislocation with associated metallosis.Review of the device history records identified no related deviations or anomalies during manufacturing.Root cause remains undetermined.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

The patient was revised to address dislocation, disassociation, and subsequent metallosis.Glenosphere was found disassociated, shoulder did have significant dusky grey material which was consistent with metallosis, area was wide debrided, and copiously irrigated with antibiotic irrigation, stem and glenoid baseplate were well fixed.No intraoperative complications.No further information is available at the time of this reporting.

• Brand Name: VERSA-DIAL/COMP TI STD TAPER
• Type of Device: PROSTHESIS, EXTREMITY
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 8757590
• MDR Text Key: 149926164
• Report Number: 0001825034-2019-02726
• Device Sequence Number: 1
• Product Code: MBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 118001
• Device Lot Number: 201410
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/21/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention