MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVRS 25MM BSPLT HA+ADPTR; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	010000589
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Pain (1994); Insufficient Information (4580)
Date of Event	12/31/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported patient underwent shoulder revision approximately 44 days post implantation due to taper disassociation from baseplate.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4): d10: item # 405889, comp rvs 2.7mm dia drl, lot # 67339898.Item # 405883, comp rvs 3.2mm drl, lot # 67405007.Item # 110003484, access 3.2mm thd steinmann 9, lot # 67257664.Item # 110031419, cr prolong 36mm brng +3, lot # 67338871.Item # 113637, comp primary stem 17mm mini, lot # 65218335.Item # 115310, comp rvrs shldr glnsp std 36mm, lot # j7960066.Item # 110031400, mini tray +5mm cocr +0 offset, lot # 67063667.Item # 180551, comp lk scr 3.5hex 4.75x20 st, lot # 67627424.Item # 180558, comp nlk scr 3.5hex 4.75x20 st, lot # 67403907.Item # 180559, comp nlk scr 3.5hex 4.75x25 st, lot # 67422159.Item # 115396, comp rvs cntrl 6.5x30mm st/rst, lot # 67418137.Item # 180550, comp lk scr 3.5hex 4.75x15 st, lot # 67420035.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported patient underwent shoulder revision approximately 44 days post implantation due to pain and taper disassociation from baseplate.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; b7; d2a; g3; g6; h2; h3; h6; h11.Visual examination of the provided photograph identified a glenosphere with a taper adapter attached and a bearing.All product have biodebris.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.The reported event was confirmed by review of x-rays.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: right reverse total shoulder arthroplasty.The final images show complete dissociation of the glenosphere from the metaglene baseplate.The glenosphere remains articulating with the humeral component and both are anteriorly dislocated.Of note, no immediate post-operative axillary view or well positioned grashey view is available to assess the baseplate glenosphere interface to ensure proper taper engagement.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.

• Brand Name: COMP RVRS 25MM BSPLT HA+ADPTR
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• 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: 24179959
• Report Number: 0001825034-2026-00205
• Device Sequence Number: 13154142
• Product Code: KWS
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K193373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2026

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: 010000589
• Device Lot Number: 67158396
• 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: 12/31/2025
• Supplement Date Received by Manufacturer: 06/10/2026
• Initial Report FDA Received Date: 01/26/2026
• Supplement Report FDA Received Date: 07/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2025
• 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.; SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 154 LB