MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VERSA-DIAL 38X19X39 HUM HEAD; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED

Model Number	N/A
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Adhesion(s) (1695); Erosion (1750); Pain (1994); Loss of Range of Motion (2032); Joint Dislocation (2374); Osteopenia/ Osteoporosis (2651); Subluxation (4525); Joint Impingement (4834)
Date of Event	10/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event is recorded by zimmer biomet under (b)(4).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 underwent an initial left total shoulder arthroplasty.The patient was subsequently revised due to pain, loss of range of motion, instability, and dislocation.During the revision, the surgeon noted adhesions, erosion, impingement, subluxation, and the head was locked anteriorly to the glenoid.The modular post, glenoid, and head were exchanged without complications.The stem remained implanted.Due diligence is complete.No additional information is available.
Additional Manufacturer Narrative
This event is recorded by zimmer biomet under (b)(4).The following sections have been updated: b4, b5, g1, g3, g6, h2, h6, h11.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: approximately 10 days post-op, the patient requested to remove the sling and start using the arm even though the surgeon advised against it.At 3 months post-op, the surgeon noted limited range of motion (rom): 70° forward flexion, 40° active external rotation without pain.Radiographs taken indicated significant anterior subluxation along with suggestive subscapular failure.The patient reported a fall early on that injured her knee but did not feel that it necessarily injured her shoulder although obviously her subscapularis repair is vulnerable early on.The surgeon noted prominence anteriorly, rom: forward elevation 30°, abduction 40°, internally rotate to ls junction, strength limited secondary to anterior dislocation.Ct scan: limited glenoid bone stock within the bones osteopenic and multiple areas of medical cortical breach.No lucency of the glenoid component, anterior subluxation of humeral head, erosive change/remodeling along the inferior glenoid rim, correlates clinically for humeral impingement, osteopenia.Emg nerve conduction study is normal.Revision operative report indicated anterior instability.The surgeon utilized the previous incision and released subdeltoid adhesions.The subscapularis and rotator cuff were noted to be intact.Further noted, the humeral head was locked anteriorly to the glenoid, head osteotomized away from the stem, stem stable and remained intact.There was significant redundant posterior labrum over the back half of the glenoid face.The surgeon noted this tissue could be what caused the humeral head to dislocate anteriorly.The tissue was excised and glenoid polyethylene excised into pieces that included the peripheral pegs and 3 pieces were removed; central post removed without difficulty.The reported event is confirmed from provided medical records.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.
Event or Problem Description
No additional information is available regarding the incident.

• Brand Name: VERSA-DIAL 38X19X39 HUM HEAD
• 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: 20706165
• Report Number: 0001825034-2024-02700
• Device Sequence Number: 12787546
• Product Code: MBF
• UDI-Device Identifier: 00880304212183
• UDI-Public: (01)00880304212183(17)331209(10)66419147
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K193038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2025

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 Model Number: N/A
• Device Catalogue Number: 113022
• Device Lot Number: 66419147
• 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: 10/22/2024
• Supplement Date Received by Manufacturer: 04/08/2025
• Initial Report FDA Received Date: 11/18/2024
• Supplement Report FDA Received Date: 04/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/09/2023
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 84 KG