MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MINI STANDARD THICKNESS +0MM TAPER HUMERAL TRAY; PROSTHESIS, SHOULDER

Catalog Number	110031399
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was revised six months post-initial implantation due to the disassociation of the humeral bearing from the humeral tray.No additional patient consequences were reported.
Additional Manufacturer Narrative
(b)(4).D10: cat: 110031425 lot: 66119333 +3mm thickness 36mm diameter bearing.Cat: 115310 lot: j7658161 comp rvrs shldr glnsp std 36mm.Customer has indicated that the product is in 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 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
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d2, d9, g3, g6, h1, h2, h3, h6, h11 corrected section: h4 complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned products identified the poly bearing shows damage to the backside and spherical radius.Damage is too severe to measure.The tray exhibits scuff marks on the rim feature and taper.Product identifiers were measured and found conforming.A revised glenosphere was also returned as the surgeon decided to change the glenosphere during the procedure.The device was not evaluated as no allegations were against the glenosphere.Devices are used for treatment.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to 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.

• Brand Name: MINI STANDARD THICKNESS +0MM TAPER HUMERAL TRAY
• 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: 20135951
• Report Number: 0001822565-2024-02813
• Device Sequence Number: 12600259
• Product Code: KWS
• UDI-Device Identifier: 00887868231315
• UDI-Public: (01)00887868231315(17)340106(10)66394119
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K181611
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 110031399
• Device Lot Number: 66394119
• 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: 08/27/2024
• Supplement Date Received by Manufacturer: 02/05/2025
• Initial Report FDA Received Date: 09/04/2024
• Supplement Report FDA Received Date: 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2024
• 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 NARRATIVE
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male