MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP VERSA DIAL RVRS SHLDR GLNSP STD 36MM; PROSTHESIS, SHOULDER

Catalog Number	115310
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Joint Impingement (4834)
Date of Event	09/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: medical products: item#: 110031399, mini standard thickness +0mm taper offset 40mm diameter humeral tray; lot#: 66625512.G2: foreign: australia.H3: customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product was discarded.H6: proposed code: mechanical (g04)- head.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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 underwent a revision surgery due to impingement.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d2; d10; g2; g3; g6; h1; h2; h6 d10: medical products: item#: 010000589, comp rvrs 25mm bsplt ha+adptr; lot#: 66269110.Item#: 115396, comp rvs cntrl 6.5x30mm st/rst; lot#: 66624463.Item#: 180554, comp lk scr 3.5hex 4.75x35 st; lot#: 65965087.Item#: 180553, comp lk scr 3.5hex 4.75x30 st; lot#: 66021367.Item#: 180559, comp nlk scr 3.5hex 4.75x25 st; lot#: 66543429.Item#: 113634, comp primary stem 14mm min; lot#: 66283594.Item#: 110031424, standard 36mm diameter bearing; lot#: 66272842.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent an initial right shoulder arthroplasty approximately one (1) year and three (3) months ago.Subsequently, the patient underwent a revision surgery approximately a month and a half ago.During revision noted notch impingement.The glenosphere, humeral tray and bearing were exchanged without complications, the baseplate, four screws, and humeral stem remained implanted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h2, h3, h6, h11.The reported event could not be confirmed due to lack of product/information.Visual examination of the provided photos identified the explanted items.However, as the products were not returned, further analysis could not be performed.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: right revision tsr due to pain/impingement (notch impingement), cephalic vein injured during scar dissection, tied off, illegible handwritten op note.The device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.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
Attempts have been made and no further information has been provided.

• Brand Name: COMP VERSA DIAL RVRS SHLDR GLNSP STD 36MM
• Common Device Name: PROSTHESIS, SHOULDER
• 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: 23378345
• Report Number: 0001825034-2025-03324
• Device Sequence Number: 13061920
• Product Code: PHX
• UDI-Device Identifier: 00880304475373
• UDI-Public: (01)00880304475373(17)330714(10)J7569381
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K080642
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/11/2026

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: Lay User/Patient
• Device Catalogue Number: 115310
• Device Lot Number: J7569381
• 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: 09/30/2025
• Supplement Date Received by Manufacturer: 10/21/2025; 03/11/2026
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 11/14/2025; 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2023
• 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: Male