MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ALLIANCE GLENOID MODULAR CENTER POST REAMER; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED

Catalog Number	SBGL3007
Medical Device Problem Codes	Crack (1135); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: foreign, the event occurred in canada.H6: proposed code: mechanical (g04), drill.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 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 that during reaming of a center post, the tip of the reamer was found to be cracked.No fragments fell into the surgical site.There were no consequences or impact to the patient.Attempts have been made and no further information has been provided.
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.The reported confirmed through evaluation or the returned product.Visual examination of the returned product/provided pictures identified shows signs of use as well as wear and tear.The shaft of the device and flange of the stepped cutting head have scratches from use.The tip of the stepped cutting head has also cracked in multiple places as shown in the photos.The reamer has a possible field age of 1.5+ years.Verified all product identifiers to confirm the reamer is conforming to print specifications.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Medical records were not provided.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: ALLIANCE GLENOID MODULAR CENTER POST REAMER
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
• 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: 23872404
• Report Number: 0001822565-2025-04732
• Device Sequence Number: 11896905
• Product Code: KWS
• UDI-Device Identifier: 00889024574779
• UDI-Public: (01)00889024574779(11)240108(10)66396162
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K191814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: SBGL3007
• Device Lot Number: 66396162
• 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: 12/01/2025
• Supplement Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown