MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE +3 36MM; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Disassembly (1168)

Patient Problem No Code Available (3191)

Event Date 08/30/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.Concomitant products: 118000, 25mm versa-dial taper adaptor, 916240.00435006500, 65 d ret 36mm vit e lnr +0mm, unk.115313, comp rvsr shldr glnsp +3 36mm, unk.118000, 25mm versa-dial taper adaptor, unk.Report source, foreign ¿ events occurred in (b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2017 - 07553.

Event Description

It was reported that the patient underwent a total reverse shoulder arthroplasty.Subsequently, the patient was revised due to disassociation of the glenosphere.During the revision, the glenosphere and poly were removed and replaced.It was noted by the surgeon that the center screw for the baseplate could be rotated, indicating it may not have been fully inserted during the primary procedure, thus contributing to the disassociation.No additional patient consequences were reported.

Manufacturer Narrative

(b)(4).Upon receipt of information received and reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.

• Brand Name: COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE +3 36MM
• 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: 6904717
• MDR Text Key: 87791191
• Report Number: 0001825034-2017-07552
• Device Sequence Number: 1
• Product Code: PAO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK080642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2017
• 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: 115313
• Device Lot Number: 295770
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2017
• 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: 79 YR