MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MINI +5MM THICKNESS +3MM TAPER OFFSET 40MM DIAMETER HUMERAL TRAY; EXTREMITY IMPLANT

Model Number	N/A
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Joint Dislocation (2374); Insufficient Information (4580)
Date of Event	07/15/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - medical product: catalog #: 110030776, standard offset 40mm diameter glenosphere, lot #: 65981737.Catalog #: 110031428, +3mm thickness 40mm diameter bearing, lot #: 65994931.H3: the customer has not indicated whether the product will be returned to zimmer biomet for investigation or not.Once this information is obtained a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the glenosphere, bearing and tray were revised on an unknown date for an unknown reason.Attempts have been made and there is no further information at this time.
Event or Problem Description
It was further reported that the patient had initial surgery on approximately 9 months ago.Subsequently, the patient had a revision about 2 months due to shoulder dislocation.Since we now know the reason for this revision this product no longer needs to be reported on as it would not have contributed to the reported event.
Additional Manufacturer Narrative
(b)(4).Updated: a1, a2, a3, b4, b5, d2, d6a, g3, h1, h2, h3, h6, h11.Since we now know the reason for this revision this product no longer needs to be reported on as it would not have contributed to the reported event.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 +5MM THICKNESS +3MM TAPER OFFSET 40MM DIAMETER HUMERAL TRAY
• Common Device Name: EXTREMITY IMPLANT
• 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: 19960152
• Report Number: 0001822565-2024-02614
• Device Sequence Number: 15220010
• Product Code: KWS
• UDI-Device Identifier: 00887868231353
• UDI-Public: (01)00887868231353(17)301027(10)64909220
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2024

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: 110031403
• Device Lot Number: 64909220
• 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: 07/19/2024
• Supplement Date Received by Manufacturer: 08/27/2024
• Initial Report FDA Received Date: 08/12/2024
• Supplement Report FDA Received Date: 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/29/2020
• 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 H10.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male