MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM GLENOSPHERE; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	00434903611
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Insufficient Information (4580); Bone Notching (4890)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event.Associated reports are available for the applicable concomitant products below in the d10 narrative.H6: proposed code: mechanical (g04)- head the customer has not indicated whether the product will be zimmer biomet for investigation, and the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Attempts have been made to gather all product identification information, and no further information has been provided.If any further information is found that 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
It was reported by the patient-matched implant (pmi) group that a patient underwent a shoulder arthroplasty procedure on an unknown date.Subsequently, the patient is being considered for a pmi product on an unknown day.Attempts have been made, and no further information has been provided.
Event or Problem Description
It was reported by the patient-matched implant (pmi) group that a patient underwent a shoulder arthroplasty procedure.Subsequently, the patient is being considered for a pmi product due to pain with onset on an unknown day, with inconsistent returns to the physician.Imaging apparently show that the patient is experiencing scapular notching.The patient has not been scheduled for a revision, and due to her past medical history may not get cleared for another procedure.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/corrected: a2; a3; b4; b5; d1; d2; d4; d6; d9; d10; g1; g3; g4; g6; h1; h2; h4; h6.D10: concomitant medical products, part (lot): 00434901213(63867902), 00434903603(63842343).Associated product information: 47430906125(63141840), 00434901500(63869345), 0104223036(2919958), 0104223027(2932864).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.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d2; d4; g1; g3; g6; h1; h2; h4.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.
Additional Manufacturer Narrative
(b)(4) this follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; d2; d9; g1; g3; g6; h1; h2; h3; h6 d10: concomitant medical products, part (lot): -00434901500(63869345) the reported event is confirmed through evaluation of medical records.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.X-rays were provided and reviewed by a health care professional.Review of the available records identified the following: there is a reverse total shoulder arthroplasty in place with non-cemented humeral component.There is deep scapular notching that extends to the inferior baseplate screw with associated bone formation off the adjacent inferior glenoid.Stress shielding is noted in the proximal humerus and there is bone loss in the proximal humeral metaphysis.Of note, the baseplate is positioned on the cranial half of the glenoid.An os acromiale and moderate acromioclavicular joint osteoarthritis incidentally noted.It was noted that the baseplate was positioned on the cranial half of the glenoid; there is no information on initial surgery.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: ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM GLENOSPHERE
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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: 23975104
• Report Number: 0001822565-2026-00073
• Device Sequence Number: 11903570
• Product Code: PHX
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K130661
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/25/2026

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: 00434903611
• Device Lot Number: 63934555
• 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: 12/08/2025
• Supplement Date Received by Manufacturer: 01/20/2026; 04/16/2026; 06/25/2026
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 02/19/2026; 04/22/2026; 06/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/26/2018
• 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; SEE H11.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 73 YR
• Patient Sex: Female