MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE REVERSE SHOULDER; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	010000589
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Aseptic loosening (4883)
Date of Event	10/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: associated product information, part (lot): 00-4349-012-13 (66927809).00-4350-036-00 (66773441).115395 (67171828).180551 (67184547).180554 (67246578).115313 (j7911611).G2: foreign - the event occurred in japan.The customer has indicated that the product is in the process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.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
It was reported that the patient experienced pain and implant loosening approximately five (5) weeks after an initial reverse shoulder arthroplasty procedure.A revision procedure was performed in which the baseplate, adapter, poly liner, and glenosphere head were replaced.The surgical technique specified for the device was used during the initial surgery.The revision surgery was successful, and no additional complications have been reported.Attempts have been made, and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d2; d9; d10; g1; g3; g6; h1; h2; h6.Multiple mdr reports were filed for this event.Associated reports are available for the applicable concomitant products in the d10 narrative below.D10: concomitant medical products, part (lot); mfr report; 115313 (j7911611); 0001825034-2026-00601.Associated product information, part (lot): 00-4349-012-13 (66927809), 00-4350-036-00 (66773441), 115395 (67171828), 180551 (67184547), 180554 (67246578).The product has been received by zimmer biomet and the investigation is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient experienced pain and implant loosening approximately five (5) weeks after an initial reverse shoulder arthroplasty procedure.The glenosphere head was found to have come loose.A revision procedure was performed in which the baseplate, adapter, poly liner, and glenosphere head were replaced.The surgical technique specified for the device was reported to have been used during the initial surgery.The revision surgery was reported as successful with no additional complications.Upon return of the product, the taper adapter was found lodged in the glenosphere.It was reported that no further information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d2; g1; g3; g6; h1; h2; h3; h6.The complaint sample was evaluated, and the reported event was confirmed.The taper adapter is angled within the glenosphere and is lodged in place.Visual examination of the returned product identified that the taper adapter returned shows signs of use as well as wear and tear.There is galling on the side of the taper adapter, as shown in the photos.There are also scratches on the visible surface of the taper adapter as well.Measured post height and confirmed etch to confirm the device is conforming.The glenosphere returned also shows signs of use.There are several scratches on the articulating surface.Measured the outer diameter of the device and verified the etch to confirm the glenosphere is conforming to the print specification.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
No further event information is available at the time of this report.

• Brand Name: COMPREHENSIVE REVERSE SHOULDER
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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: 23533657
• Report Number: 0001825034-2025-03576
• Device Sequence Number: 9020966
• Product Code: PHX
• UDI-Device Identifier: 00880304532465
• UDI-Public: (01)00880304532465(17)350709(10)67218480
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K120121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 04/24/2026

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: 67218480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 10/17/2025
• Supplement Date Received by Manufacturer: 02/17/2026; 04/24/2026
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 03/16/2026; 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2025
• 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: H11.; H11.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown