MAUDE Adverse Event Report: ZIMMER BIOMET, INC. GLENOSPHERE 36 MM DIAMETER; SHOULDER PROSTHESIS

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Erosion (1750); Unspecified Infection (1930); Osteolysis (2377)

Event Date 07/31/2020

Event Type  Injury  

Manufacturer Narrative

Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.Item number: 00434903811, item name: base plate, lot number: 62562700.Item number: 00434901413, item name: humeral stem, lot number: 62363960.Item number: 00434903600, item name: poly liner, lot number: 62890677.Foreign report source: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-03036.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported patient underwent a shoulder revision surgery approximately 5 years post-implantation due to dissociation, osteolysis and scapular notching.During the revision, signs of an infection were noted upon removal of the glenoid components.All products were removed and replaced with antibiotic cement spacer molds.No additional information is available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of x-rays by a third party hcp noting glenosphere dissociation without dislocation.Osteolysis along the glenoid implant of the reverse type right should arthroplasty.Dhr was reviewed and no discrepancies were found.The root cause is unable to 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 additional event information to report at this time.

• Brand Name: GLENOSPHERE 36 MM DIAMETER
• Type of Device: SHOULDER PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10451320
• MDR Text Key: 204336534
• Report Number: 0001822565-2020-03035
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: K130661
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 12/29/2020

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: 00434903611
• Device Lot Number: 62868099
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/30/2020
• Initial Date FDA Received: 08/25/2020
• Supplement Dates Manufacturer Received: 12/22/2020
• Supplement Dates FDA Received: 12/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: PLEASE SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 83