MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE VRS GLENOID PATIENT MATCHED; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number 110027734

Device Problems Use of Device Problem (1670); Malposition of Device (2616)

Patient Problem Osteopenia/ Osteoporosis (2651)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The customer has not indicated whether the product will be zimmer biomet for investigation, and it may remain 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 during a surgery, the surgeon questioned why the central screw was not reading the amount that was recorded on the screw schematic.It was observed that the implant most likely was not seated correctly.After a review of the 3d-modeled surgical plan, it was discovered that the implant had been implanted upside down.No patient consequences or plans for revision have been communicated at this time.Attempts have been made, and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D10: associated product information, part number (lot number): ¿ 110031378 (66518780).¿ 110019066 (66518781).¿ 110019066-01 (66518782).¿ 110019066-02 (66518783).If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

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

• Brand Name: COMPREHENSIVE VRS GLENOID PATIENT MATCHED
• 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: 18872230
• MDR Text Key: 337291125
• Report Number: 0001825034-2024-00643
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00880304818934
• UDI-Public: (01)00880304818934(17)240719(10)66518779
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K202232
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 110027734
• Device Lot Number: 66518779
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2024
• 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
• Patient Outcome(s): Other
• Patient Sex: Male