MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP LOCKING SCREW 4.75X35MM; PROSTHESIS, SHOULDER

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Joint Dislocation (2374)

Event Date 02/01/2011

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(4).Concomitant medical products: comprehensive taper - cat.No.118001, lot no.761510, humeral tray ¿ cat.No.115340, lot no.457900, hydroxyapatite porous coat ¿ cat.No.115330, lot no.550050, screw ¿ cat.No.115381, lot no.831360, fixed screw ¿ cat.No.180500, lot no.219550, humeral stem ¿ cat.No.113852, lot no.924010, adapter ¿ cat.No.118001, lot no.781510, crs standard bmt ¿ cat.No.115310, lot no.535460, humeral bearing ¿ cat.No.Xl-115363, lot no.702700, fixed locking screw ¿ cat.No.180504, lot no.852160, fixed locking screw ¿ cat.No.180501, lot no.971940.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 05118, 0001825034 - 2018 - 05119, 0001825034 - 2019 - 00647, 0001825034 - 2019 - 00648, 0001825034 - 2019 - 00650.Reported event was confirmed by review of operative notes and x-rays post initial surgery.As per the x rays post initial surgery, surgeon had pulled the glenosphere off of the glenoid with loss of articulations.As per the revision surgery operative notes, the glenosphere was completely pulled off the glenoid.The actual glenosphere locking screws remained intact.There was a small bony defect where the central screw fit into the glenoid where it pulled off.There was a prominence of a broken screw.This was posterior most screw that was broken and protruded.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.Not returned to manufacturer.

Event Description

It was reported patient had comprehensive reverse shoulder revision surgery in less than two (2) months post initial surgery due to disassociation of the glenosphere which may have resulted into fracture of posterior most screw.No additional patient consequences were reported.

• Brand Name: COMP LOCKING SCREW 4.75X35MM
• Type of Device: PROSTHESIS, SHOULDER
• 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: 8344090
• MDR Text Key: 136289275
• Report Number: 0001825034-2019-00649
• Device Sequence Number: 1
• Product Code: PHX
• 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: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/14/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 180504
• Device Lot Number: 905450
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/05/2019
• Initial Date FDA Received: 02/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2010
• 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
• Patient Outcome(s): Hospitalization; Required Intervention