MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOMET COMP RVS CNTRL 6.5X30MM ST/RST; SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES

Catalog Number	115396
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	06/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: medical products: item#: 115310, comp rvrs shldr glnsp std 36mm; lot#: j7736645, item#: 110031424, standard 36mm diameter bearing; lot#: 66522170, item#: 110031402, mini standard thickness +3mm taper offset 40mm diameter humeral tray; lot#: 66300012, item#: 010000589, comp rvrs 25mm bsplt ha+adptr; lot#: 66225604, item#: 180552, comp lk scr 3.5hex 4.75x25 st; lot#: 65905037, item#: 180552, comp lk scr 3.5hex 4.75x25 st; lot#: 66447229, item#: 180551, comp lk scr 3.5hex 4.75x20 st; lot#: 66528295, item#: 180551, comp lk scr 3.5hex 4.75x20 st; lot#: 66676453, item#: 113630, comp primary stem 10mm mini; lot#: 65886151.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.
Event or Problem Description
It was reported that the patient underwent an initial right shoulder arthroplasty approximately ten (10) months ago.Subsequently, approximately sixteen (16) days after the patient's initial surgery the patient underwent a revision surgery due to the dislocation of the implants.During the revision surgery it was determined by the surgeon that the central screw was not fully seated.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: b4; b5; d2; g2; g3; g6; h1; h2; h3; h6.The following section was corrected: d5, d6b.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: right reverse tsa performed.During follow up x-rays show displacement of glenosphere, baseplate and stem remain well seated, no evidence of fracture.Radiology report: glenoid prosthetic component dislocated superiorly.Patient was revised and it was determined that the central screw may have not been fully seated.However, the screw could not be further tightened and had good purchase.The 30mm screw was removed, and not replaced as compression was already achieved, and peripheral locking screws were well secured.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.

• Brand Name: BIOMET COMP RVS CNTRL 6.5X30MM ST/RST
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION/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: 21899789
• Report Number: 0001825034-2025-01196
• Device Sequence Number: 12939752
• Product Code: PHX
• UDI-Device Identifier: 00880304677081
• UDI-Public: (01)00880304677081(17)330906(10)66256585
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K193373
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2025

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: Lay User/Patient
• Device Catalogue Number: 115396
• Device Lot Number: 66256585
• 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: 03/31/2025
• Supplement Date Received by Manufacturer: 09/29/2025
• Initial Report FDA Received Date: 04/24/2025
• Supplement Report FDA Received Date: 09/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/06/2023
• 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: 65 YR
• Patient Sex: Male
• Patient Weight: 98 KG
• Patient Race: White