MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SM HYBRID GLENOID BASE 4MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Failure of Implant (1924); Pain (1994); Metal Related Pathology (4530)
Date of Event	10/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was revised due to a crack in an unknown implant.There was harm or injury to patient as the patient had to underwent a revision due to the cracked implant and subsequent pain.There was no reported contributing conditions related to the event.Due diligence is complete.No additional information is available.
Additional Manufacturer Narrative
This event is recorded by zimmer biomet under (b)(4).D10 narrative: item : pt-113950 lot # : 799330 item name: pt hybrid glen post regenerex item : 118001 lot # : 261990 item name: versa-dial/comp ti std taper item : 113632 lot # : 898030 item name: comp primary stem 12mm mini item : 113042 lot # : 845780 item name: versa-dial 46x18x53 hum head the product is in the process of being evaluated by zimmer biomet.Once the product investigation has been completed, a follow up/final report will be submitted.
Event or Problem Description
It was reported that the patient was revised due to pain and aseptic implant loosening.Intraoperatively, metallosis and poly wear were noted as well as a broken ingrowth peg and fractured glenoid.Revision to a reverse total shoulder was successfully completed with no additional complications noted, further details have not been provided at this time.
Additional Manufacturer Narrative
This event is recorded by zimmer biomet under (b)(4).D10 narrative: item : pt-113950.Lot # : 799330.Item name: pt hybrid glen post regenerex.Item : 118001.Lot # : 261990.Item name: versa-dial/comp ti std taper.Item : 113632.Lot # : 898030.Item name: comp primary stem 12mm mini.Item : 113042.Lot # : 845780.Item name: versa-dial.46x18x53 hum head.The product is in the process of being evaluated by zimmer biomet.Once the product investigation has been completed, a follow up/final report will be submitted.
Event or Problem Description
No additional information is available regarding the incident.
Additional Manufacturer Narrative
This event is recorded by zimmer biomet under (b)(4).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.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: the previous metal humeral head was removed using a tuning fork, there was significant metallosis and poly wear with darkening of the soft tissues that were removed using electrocautery.Retractors were then placed into the anterior and posterior edges of the glenoid, the poly glenoid component was obviously loose, an osteotome was placed beneath it and it was easily removed.There was good bone beneath it.The bone cement stayed on the back of the polyethylene.The tantalum ingrowth peg had snapped off with the screw still inside of it making extraction difficult.In order to get it out the anterior rim of the glenoid fractured off while gaining access to the peg which then allowed it to be removed with a large rongeur.Radiographs were not provided.A definitive root cause cannot be determined.The reported event is confirmed from provided operative notes.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.

• Brand Name: SM HYBRID GLENOID BASE 4MM
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
• 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: 20772548
• Report Number: 0001825034-2024-02780
• Device Sequence Number: 20867262
• Product Code: MBF
• UDI-Device Identifier: 00880304462625
• UDI-Public: (01)00880304462625(17)220513(10)332180
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K193038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/19/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/13/2022
• Device Model Number: N/A
• Device Catalogue Number: 113952
• Device Lot Number: 332180
• 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: 11/01/2024
• Supplement Date Received by Manufacturer: 12/11/2024; 03/14/2025
• Initial Report FDA Received Date: 11/25/2024
• Supplement Report FDA Received Date: 01/06/2025; 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/13/2017
• 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: Required Intervention; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 51 KG