MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN PERIPHERAL SCREW; SHOULDER IMPLANT/EXTREMITIES

Catalog Number UNKNOWN

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

Patient Problems Pain (1994); Osteolysis (2377)

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10: medical products: item#: unknown, unknown glenoid lot#: unknown; item#: unknown, unknown central screw, lot#: unknown; item#: unknown, unknown peripheral screw, lot#: unknown; item#: unknown, unknown peripheral screw, lot#: unknown; item#: unknown, unknown peripheral screw, lot#: unknown.H3: customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted in the patient.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 left shoulder arthroplasty on and unknown date.Subsequently, the patient is being considered for a revision surgery due to glenoid bone loss that has caused the patient pain and possible loosening of implants.Multiple attempts have been made for additional information, but no additional information has been received at this time.

• Brand Name: UNKNOWN PERIPHERAL SCREW
• Type of Device: SHOULDER IMPLANT/EXTREMITIES
• 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: 19115436
• MDR Text Key: 340338894
• Report Number: 0001822565-2024-01254
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H11 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention