MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP CONV GLEN LINER E1; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/03/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: item #: unknown, unknown base plate, lot #: unknown; item #: unknown, unknown humeral stem, lot #: unknown; item #: unknown, unknown glenosphere, lot #: unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The product was discarded by the hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported a patient underwent a right shoulder arthroplasty.Three years post implantation, the convertible poly was found to be broken in half upon examining the shoulder prosthesis and patient was revised.No additional information is available.

Event Description

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

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Updated: b4, b5, g3, h2, h3, h6.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies related to the event 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.

• Brand Name: COMP CONV GLEN LINER E1
• 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: 12846665
• MDR Text Key: 281071776
• Report Number: 0001825034-2021-03070
• Device Sequence Number: 1
• Product Code: MBF
• UDI-Device Identifier: 00880304567948
• UDI-Public: (01)00880304567948(17)231026(10)375420
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/26/2023
• Device Model Number: N/A
• Device Catalogue Number: 110005237
• Device Lot Number: 375420
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2018
• 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
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male