MAUDE Adverse Event Report: ZIMMER BIOMET, INC. GLENOSPHERE CENTRIC 40 MM DIAMETER +0 MM LATERAL OFFSET; PROSTHESIS SHOULDER

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem Bone Fracture(s) (1870)

Event Date 05/19/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: catalog #: 00436203000, base plate uncemented 30 mm post length, lot # 64509369.Catalog #: 0104223042, anatomical shoulder reverse, screw system, lot # 3021682.Catalog #: 0104223036, anatomical shoulder reverse, screw system, lot # 3046119.Report source: (b))(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as its location is unknown.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: 0001822565-2021-01611.

Event Description

It was reported during an initial shoulder procedure, the patient's bone fractured when retracting to place the glenosphere.The surgeon was performing a bio rsa technique reverse shoulder replacement with the tmr+ glenoid components, surgical technique was followed to implant baseplate and screws.On insertion of the glenosphere, the surgeon struggled to place the glenosphere on the taper.While retracting to place the glenosphere the patient's glenoid was fratcured.There was a 30 minute delay due to finding a way to appropriately treat the fracture.Attempts have been made and there is no further information at this time.

Manufacturer Narrative

(b)(4).Updated: b4, b5, d4 (udi), g3, h1, h2, h3, h6, h10.Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause could not be determined.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

No further event information available at the time of this report.

• Brand Name: GLENOSPHERE CENTRIC 40 MM DIAMETER +0 MM LATERAL OFFSET
• Type of Device: PROSTHESIS SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11974124
• MDR Text Key: 255959630
• Report Number: 0001822565-2021-01610
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• PMA/PMN Number: K172767
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00436004000
• Device Lot Number: 64528397
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Other