MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP REV MINI TRAY STD COCR +0 OFFSET; SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES

Catalog Number	110031399
Medical Device Problem Codes	Mechanical Jam (2983); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Joint Impingement (4834)
Date of Event	09/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: medical products: item#: 110031424, standard 36mm diameter bearing; lot#: 66272842.Item#: 115310, comp rvrs shldr glnsp std 36mm; lot#: j7569381.Item#: 115396, comp rvs cntrl 6.5x30mm st/rst; lot#: 66624463.Item#: 010000589, comp rvrs 25mm bsplt ha+adptr; lot#: 66269110.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 mini; lot#: 66283594.G2: foreign: australia.H3: customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product was discarded.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 due to impingement and pain.During the 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.Visual examination of the provided photos identified the explanted items.However, as the products were not returned, no further analysis could be performed.The device history record was reviewed and no discrepancies relevant to the reported event were found.Medical records were provided and reviewed by a health care professional.Review of the available record identified the following: right revision tsr due to pain/impingement (notch impingement), cephalic vein injured during scar dissection, tied off.Root cause has been identified as notch type impingement or scapular notching is attributed to the baseplate, taper adapter and glenophere.These items dictate the offset that will prevent the bearing from coming in to contact with the glenoid bone.These items are all captured under the linked complaint.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 REV MINI TRAY STD COCR +0 OFFSET
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 23544139
• Report Number: 0001822565-2025-04114
• Device Sequence Number: 13205507
• Product Code: PHX
• UDI-Device Identifier: 00887868231315
• UDI-Public: (01)00887868231315(17)340506(10)66625512
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K181611
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 110031399
• Device Lot Number: 66625512
• 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: 10/21/2025
• Supplement Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2024
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 69 YR
• Patient Sex: Male