MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE REVERSE SHOULDER CENTRAL SCREW; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number 115396

Device Problems Detachment of Device or Device Component (2907); Migration (4003)

Patient Problem Bruise/Contusion (1754)

Event Date 02/15/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10: associated product information, part number (lot number): ¿ 118000-00 (66400665) ¿ unknown tray (unknown) ¿ unknown bearing (unknown) the product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found that would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported that a few days following an initial arthroscopy procedure, the patient experienced implant dissociation.The patient was successfully revised approximately one (1) week following the original procedure, and the surgeon discovered that the central screw wasn't fully tightened, causing the malfunction.This device was explanted and replaced with an alternate device during the revision successfully, with no other patient harm reported.Attempts have been made, and no further information has been provided.

Event Description

It was reported that a few days following an initial arthroscopy procedure, the patient experienced implant dissociation.The patient was successfully revised approximately one (1) week following the original procedure, and the surgeon discovered that the central screw wasn't fully tightened, causing the looseness.The screw was adjusted, and no other patient harm was reported.Attempts have been made, and no further information has been provided.

Manufacturer Narrative

(b)(4).Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided, and a corrected report will be filed under the mfr number 1825034 biomet.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: COMPREHENSIVE REVERSE SHOULDER CENTRAL SCREW
• Type of Device: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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: 18899629
• MDR Text Key: 337618654
• Report Number: 0001822565-2024-00901
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181611
• 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,Followup
• Report Date: 04/29/2024

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 Catalogue Number: 115396
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 02/29/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/13/2024
• Supplement Dates Manufacturer Received: 04/03/2024
• Supplement Dates FDA Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/24/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Treatment: H10; H11
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male