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

Catalog Number 115396

Device Problem Migration (4003)

Patient Problem Bruise/Contusion (1754)

Event Date 02/15/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10: concomitant medical products, part number (lot number): ¿ 110027734 (66500759) ¿ 110031378 (66500762) associated product information: ¿ 113633 (64964350) ¿ 180554 (unknown) ¿ 180554 (unknown) ¿ 180555 (unknown) ¿ 180555 (unknown) ¿ 180556 (unknown) ¿ 405800 (66394301) ¿ 110010066 (66500764) ¿ 110030777 (66072611) ¿ 110031400 (66394125) ¿ 110031429 (65434183) this report was initially reported under the incorrect mfr number (0001822565-2024-00901).The customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.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 underwent additional surgery 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 other concomitant devices were retained during the revision, with no other patient harm reported.Attempts have been made, and no further information has been provided.

• Brand Name: COMPREHENSIVE REVERSE SHOULDER CENTRAL SCREW
• Type of Device: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19207292
• MDR Text Key: 341322196
• Report Number: 0001825034-2024-01095
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193373
• 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: 04/29/2024

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/03/2024
• Initial Date FDA Received: 04/29/2024
• 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: H11
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male