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

Catalog Number 180553

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

Patient Problem Osteopenia/ Osteoporosis (2651)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2024-00509, 0001825034-2024-00510, 0001825034-2024-00511.D10: item# 010000589; lot# 928910, item# 115395; lot# 988780, item# 180552; lot# 856440, item# 110035372; lot# x12aaf1707, item# 00434901013; lot# 65492269, item# 00435003603; lot# 65243570, item# 00801102016; lot# 65346659.G2: foreign - event occurred in japan.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot 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

It was reported that the patient underwent an initial shoulder arthroplasty approximately one (1) year and two (2) months ago.Subsequently, the patient was indicated for a revision with pmi product due to alleged baseplate loosening.The reporter also noted an apparent problem with the patient's bone quality.A revision has not been confirmed at this time.Attempts have been made and no further information has been provided.

• Brand Name: COMPREHENSIVE REVERSE SHOULDER FIXED LOCKING 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: 19116215
• MDR Text Key: 340338399
• Report Number: 0001825034-2024-00512
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00880304677166
• UDI-Public: (01)00880304677166(17)320809(10)919260
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K132239
• 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
• Report Date: 04/16/2024

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: 180553
• Device Lot Number: 919260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/17/2023
• Initial Date FDA Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2022
• 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
• Patient Outcome(s): Other
• Patient Sex: Female