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

Model Number N/A

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Osteopenia/ Osteoporosis (2651)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: catalog #: unknown, humeral head, lot # unknown.Catalog #: unknown, humeral stem, lot # unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the hospital would not return it.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Requested but not returned by hospital.

Event Description

It was reported that the patient underwent a right shoulder procedure on an unknown date.Subsequently the patient has been indicated for a revision as the glenoid has come loose, there is also severe bone loss.No additional information available at this time.

Manufacturer Narrative

(b)(6).Reported event was unable to be confirmed due to limited information received from the customer.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 as the necessary information to adequately investigate the reported event was not provided.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.

Event Description

It was further reported that the surgery was never performed.No further event information available at the time of this report.

Manufacturer Narrative

(b)(4).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.

• Brand Name: UNKNOWN GLENOID COMPONENT
• Type of Device: PROSTHESIS SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9915307
• MDR Text Key: 186747463
• Report Number: 0001825034-2020-01278
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 05/13/2021

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/16/2020
• Initial Date FDA Received: 04/02/2020
• Supplement Dates Manufacturer Received: 04/16/2020; 04/20/2021
• Supplement Dates FDA Received: 04/17/2020; 05/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention