MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SIZE 2 AUGMENT REAMER; PROSTHESIS, SHOULDER

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994)
Date of Event	03/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the original procedure approximately 9 months ago a fracture of the glenoid occurred.It was determined that there was not enough bone to cement in an anatomic implant or press fit a reverse implant.The doctor opted for a hemi shoulder construct to preserve and let the remaining bone heal.Revision is scheduled in one month.Attempts have been made and there is no further information at this time.
Additional Manufacturer Narrative
(b)(4).D10 - medical product: catalog #: sahs1209, size 9 micro humeral stem, lot # 65620305; catalog #: sahaf135, 135â° humeral stem adapter, lot # 66002349; catalog #: sahha001, humeral head adapter, lot # 66201588.H3: customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, g3, g6, h1, h2, h3, h6, h11.The following sections were corrected: b3, b5, d1, d2, d4, g4, h4 h5, h6 (health impact code), h8.H6: component code- proposed code: mechanical (g04)-drill.Reported event was unable to be confirmed due to limited information received from the customer.Visual examination of the provided photos identified the product shows minimal signs of use.No specific damage can be seen.Device is used for treatment.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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
It was reported that the patient was revised 11 months post initial procedure due to fracture of the glenoid and pain.It was determined that there was not enough bone to cement in an anatomic implant or press fit a reverse implant.The doctor opted for a hemi shoulder construct to preserve and let the remaining bone heal.No additional patient consequences were reported.

• Brand Name: SIZE 2 AUGMENT REAMER
• Common Device Name: PROSTHESIS, SHOULDER
• 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: 21267357
• Report Number: 0001822565-2025-00198
• Device Sequence Number: 8468061
• Product Code: KWT
• UDI-Device Identifier: 00889024575158
• UDI-Public: (01)00889024575158(11)200224(10)64697911
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K193180
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 05/06/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: SBGL3702
• Device Lot Number: 64697911
• 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: 01/06/2025
• Supplement Date Received by Manufacturer: 04/07/2025
• Initial Report FDA Received Date: 01/29/2025
• Supplement Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Other
• Patient Age: 61 YR
• Patient Sex: Female