MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN GLENOID; SHOULDER PROSTHESIS/EXTREMITIES

Model Number N/A

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Arthritis (1723); Pain (1994); Loss of Range of Motion (2032); Synovitis (2094); Osteolysis (2377); Tissue Breakdown (2681); Swelling/ Edema (4577)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2021-03366, 0001822565-2021-03367.Concomitant products: medical products: item#: unknown, unknown humeral head; lot#: unknown.Item#: unknown, unknown humeral stem; lot#: unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient underwent an initial right shoulder arthroplasty approximately eleven (11) years ago.Subsequently, the patient is experiencing pain and severe arthritis that is causing the patient to be unable to use right arm.Mri results received noted osteolysis and rotator cuff tear.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records received.Review of the available records identified probable osteolysis along the medial aspect of the humeral neck, additionally the humeral component is high riding secondary to secondary to underlying rc tear.Moderate to large glenohumeral joint effusion with synovitis.Findings suggest osteolysis involving the neck of the humerus medially.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.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.

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/corrected information.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2021-03366-2; 0001822565-2021-03367-2.Upon receiving additional information of the reported event, it was determined to be not reportable.The final report should be voided.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

It was reported by the patient, approximately eleven (11) years post initial left total shoulder arthroplasty, that they were having pain, severe arthritis, and unable to use arm.The patient underwent an mri and that report identified tendon tears, osteoarthritis, synovitis effusion and bursitis.No further information was provided.

• Brand Name: UNKNOWN GLENOID
• Type of Device: SHOULDER PROSTHESIS/EXTREMITIES
• 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: 12861708
• MDR Text Key: 281159355
• Report Number: 0001822565-2021-03368
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/02/2022

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 Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/02/2021
• Initial Date FDA Received: 11/23/2021
• Supplement Dates Manufacturer Received: 12/16/2021; 02/10/2022
• Supplement Dates FDA Received: 01/01/2022; 03/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 NARRATIVE
• Patient Outcome(s): Other