MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP AUG MINI BSPLT W TPR MD; SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES

Catalog Number	110032420
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Osteopenia/ Osteoporosis (2651)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial left shoulder arthroplasty on an unknown date with a competitor's products.The patient then underwent a revision surgery approximately one (1) year and four (4) months ago due to an unknown reason.Subsequently, the patient is being considered for a revision surgery due to the implant loosening and bone loss.
Additional Manufacturer Narrative
D10: medical products: item#:180550, comp lk scr 3.5hex4.75x15 st; lot#: 66127625.Item#:180550, comp lk scr 3.5hex4.75x15 st; lot#: 66127625.Item#:180552, comp lk scr 3.5hex4.75x25 st; lot#: 099800.Item#:180551, comp lk scr 3.5hex4.75x20 st; lot#: 66089150.Item#: 115395, comp rvs cntrl 6.5x25mm st/rst; lot#: 862600.H3: customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted in the patient.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.H10: related report numbers: 0001825034-2024-02819.0001825034-2024-02820.0001825034-2024-02821.0001825034-2024-02822.0001825034-2024-02823.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.A definitive root cause cannot be determined.It was noted that the glenoid had bone destruction during the revision from exachtech to comprehensive which could be a contributing factor to glenoid loosening/fixating and the need to request a pmi/vrs configuration.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 or Problem Description
No further event information available at the time of this report.

• Brand Name: COMP AUG MINI BSPLT W TPR MD
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES
• 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: 20831423
• Report Number: 0001825034-2024-02818
• Device Sequence Number: 18302332
• Product Code: PHX
• UDI-Device Identifier: 00880304993242
• UDI-Public: (01)00880304993242(17)280321(10)65612804
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K172502
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 110032420
• Device Lot Number: 65612804
• 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: 11/05/2024
• Supplement Date Received by Manufacturer: 05/08/2025
• Initial Report FDA Received Date: 12/03/2024
• Supplement Report FDA Received Date: 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/21/2023
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown