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

Model Number N/A

Device Problem Detachment Of Device Component (1104)

Patient Problem No Code Available (3191)

Event Date 03/19/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 115330, comp rvrs shdr glen bsplt +ha, 322750, 115370, comp rvs tray co 44mm, 654490, 113654, comp primary stem 14mm std, 287120, ti-115313, comp vrsdl glnspr 36mm +3 ti, 799480, xl-115364, arcom xl 44-36 std +3 hmrl brg, 256230, 115395, comp rvs cntrl 6.5x25mm st/rst, 711530, 180559, comp nlk scr 3.5hex 4.75x25 st, 916660, 180560, comp nlk scr 3.5hex 4.75x30 st, 900470, 180559, comp nlk scr 3.5hex 4.75x25 st, 150290, 180552, comp lk scr 3.5hex 4.75x25 st, 653810.Reported event was confirmed by review of the provided revision op notes.Per the revision operative report, pre-op x-rays confirmed that the glenosphere had pulled out of the baseplate.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 02404.

Event Description

It was reported by the patient¿s legal counsel that the patient underwent right shoulder arthroplasty.Legal counsel further reports patient underwent a revision procedure due to mechanical disassociation of right shoulder arthroplasty.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.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.

• Brand Name: VERSA-DIAL/COMP TI STD TAPER
• Type of Device: SHOULDER, PROSTHESIS
• 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: 7402883
• MDR Text Key: 104567903
• Report Number: 0001825034-2018-02403
• Device Sequence Number: 1
• Product Code: MBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK060716
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 118001
• Device Lot Number: 780060
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/03/2014
• 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
• Patient Age: 70 YR