MAUDE Adverse Event Report: ZIMMER BIOMET, INC. GLENOID COMPONENT PEGGED 46 MM DIAMETER ARTICULAR SURFACE; EXTREMITIES IMPLANT

Model Number N/A

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

Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924)

Event Date 08/17/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: catalog #: 00430001113, modular humeral stem 11 mm stem diameter 130 mm, lot # 60016771, catalog #: 00430204618, offset modular humeral head 18 mm head height 46 mm, lot # 73209000.Foreign source: australia.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-02500, 0001822565-2022-02501.

Event Description

It was reported a patient underwent a right shoulder arthoplasty approximately 9 years ago.Subsequenlty, patient was revised about 2 weeks ago.Loosening of humeral stem and fracture on scapula.Revision surgery delayed until patient medically fit.

Manufacturer Narrative

(b)(4).Reported event was confirmed as visual examination of the returned stem identified the dry blast finish has been worn at both proximal and distal ends of the humeral stem.The poly glenoid exhibits damage to all features with material missing.Bone cement remains on the backside.Also, the radiographs review identified the following: per report large periprosthetic lucency surrounding the humeral stem consistent with loosening.Overall fit of the humeral hardware is normal, however there is abnormal positioning of the humeral component related to the loosening causing eccentric positioning of the humeral stem tip.No other issues or abnormalities noted.Device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause could not 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 further event information available at the time of this report.

• Brand Name: GLENOID COMPONENT PEGGED 46 MM DIAMETER ARTICULAR SURFACE
• Type of Device: EXTREMITIES IMPLANT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15349080
• MDR Text Key: 299175321
• Report Number: 0001822565-2022-02502
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K103404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2007
• Device Model Number: N/A
• Device Catalogue Number: 00430008600
• Device Lot Number: 77709100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2002
• 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): Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 84 KG