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

Catalog Number	180552
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Osteopenia/ Osteoporosis (2651)
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2024-00509, 0001825034-2024-00510, and 0001825034-2024-00512.D10: item# 010000589; lot# 928910.Item# 115395; lot# 988780.Item# 180553; lot# 919260.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.

• Brand Name: COMPREHENSIVE REVERSE SHOULDER FIXED LOCKING SCREW
• Common Device Name: 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: 19116224
• Report Number: 0001825034-2024-00511
• Device Sequence Number: 12566761
• Product Code: PHX
• UDI-Device Identifier: 00880304677159
• UDI-Public: (01)00880304677159(17)320802(10)856440
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K132239
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: 180552
• Device Lot Number: 856440
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2023
• Initial Report FDA Received Date: 04/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NI
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female