MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK TM GLENOID; PROSTHESIS SHOULDER

Model Number N/A

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

Patient Problems Cyst(s) (1800); Pain (1994); Loss of Range of Motion (2032)

Event Date 12/11/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The customer has not indicated whether the product will be returned to zimmer biomet for investigation or not.Once this information is obtained a follow-up mdr will be submitted.

Event Description

It was reported that the patient underwent right total shoulder approximately 8 years ago.Subsequently, patient was revised about 9 months ago due to mechanical loosening of the glenoid component.

Event Description

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

Manufacturer Narrative

(b)(4).Updated: b4, b5, g4, h1, h2, h6, h10.Reported event was confirmed as medical records stated that the glenoid component was loose and removed.There was a defect in the glenoid.Cysts in the glenoid were debrided.Defects in the glenoid were relatively shallow and cancellous bone graft would not stay contained.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 however patient anatomy with shallow defects on the glenoid may contribute to loosening.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: UNK TM GLENOID
• Type of Device: PROSTHESIS SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10384703
• MDR Text Key: 202189254
• Report Number: 0001822565-2020-02840
• 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: consumer,other
• Type of Report: Initial,Followup
• Report Date: 10/29/2020

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/24/2020
• Initial Date FDA Received: 08/10/2020
• Supplement Dates Manufacturer Received: 10/29/2020
• Supplement Dates FDA Received: 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNKNOWN HUMERAL HEAD.; UNKNOWN HUMERAL STEM.; UNKNOWN HUMERAL HEAD.; UNKNOWN HUMERAL STEM.
• Patient Outcome(s): Hospitalization; Required Intervention