MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VERSA-DIAL 46X18X53 HUM HEAD; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED/EXTREMITIES

Catalog Number	113042
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Osteopenia/ Osteoporosis (2651); Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial shoulder arthroplasty on an unknown date.Subsequently, the patient is being considered for a revision surgery on an unknown date due to an unknown reason using a custom vrs implant.Attempts have been made to obtain additional information.No additional information has been received at this time.
Additional Manufacturer Narrative
(b)(4).D10: medical products: item#: 113042, versa-dial 46x18x53 hum head; lot#: unknown.Item#: 113632, comp primary stem 12mm mini; lot#: unknown.H3: customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.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.Attempts have been made to gather all product identification information, and no further information has been provided.The following sections were updated: b4; b5; d2; g2; g3; g6; h1; h2; h3; h6.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.Medical records were not provided.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 or Problem Description
No further event information available at the time of this report.
Event or Problem Description
It was reported that the patient underwent an initial shoulder arthroplasty approximately seven (7) months ago.Subsequently, the patient is being considered for a revision surgery using a custom implant due to the patient's glenoid bone not being sufficient.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: b4; g2; g3; g6; h1; h2; h3; h6.The following sections were corrected: b5; d1; d2; d4; g4; h4.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.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: the glenoid exhibits large old sclerotic ununited in-situ subchondral sclerotic bone fragment which may be sequela of old ununited fracture or avascular necrosis.At the superior glenoid, there were also subchondral cystic and erosive changes.A definitive root cause cannot be determined for the bone erosion.Development of a cyst is a non-procedural or implant related event, that can occur at any time during a person¿s lifetime regardless of a surgical procedure or implant.Cyst by definition are abnormal, closed sac or capsule like structures within tissue or bone that can contain different substances, such as gas, fluid, or semisolid.Size and shape can vary, as well as the cyst can grow in size over time.Cysts can resolve on their own without medical intervention, as the body just absorbs them or they can require medical intervention.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: VERSA-DIAL 46X18X53 HUM HEAD
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED/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: 22003640
• Report Number: 0001825034-2025-01376
• Device Sequence Number: 7220585
• Product Code: MBF
• UDI-Device Identifier: 00880304212220
• UDI-Public: (01)00880304212220(17)341008(10)66782794
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K060716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/29/2025

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: 113042
• Device Lot Number: 66782794
• 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: 04/18/2025
• Supplement Date Received by Manufacturer: 05/27/2025; 09/30/2025
• Initial Report FDA Received Date: 05/12/2025
• Supplement Report FDA Received Date: 06/19/2025; 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown