MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VERSA-DIAL GLENOSPHERE STANDARD; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 08/02/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 113650,comprehensive humeral stem, 887520.The 010000589,comprehensive mini baseplate and taper adaptor, 314230.Xl-115368,arcomxl retentive +3 mm humeral bearing, 976440.The 115370,cobalt chrome standard humeral tray, 005740.The investigation is in process.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: 0001825034-2018-08529, 0001825034-2018-08531, 0001825034-2018-08533, 0001825034-2018-08534.Not returned to manufacturer.

Event Description

It was reported the patient underwent a left reverse total shoulder arthroplasty revision surgery due to unknown reasons, approximately three (3) weeks following prior shoulder revision.Attempts have been made and no further information has been provided.

Event Description

Upon receipt of additional information it has been determined that this device did not cause or contribute to the reported event.The initial report was submitted in error and should be voided.

Manufacturer Narrative

(b)(4).Upon receipt of additional information it has been determined that this device did not cause or contribute to the reported event.The initial report was submitted in error and should be voided.

• Brand Name: VERSA-DIAL GLENOSPHERE STANDARD
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7812868
• MDR Text Key: 118124059
• Report Number: 0001825034-2018-08532
• Device Sequence Number: 1
• Product Code: PAO
• Combination Product (y/n): N
• PMA/PMN Number: PK080642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 02/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 115320
• Device Lot Number: 073170
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 52 YR