MAUDE Adverse Event Report: ZIMMER BIOMET, INC. +3MM THICKNESS 40MM DIAMETER BEARING; EXTREMILTY IMPLANT

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	05/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient dislocated one day after the primary surgery.Upon revising, it was noted that the proximal humerus had fractured, causing the uncemented stem to destabilise move distally, creating instability in the joint construct.The patient prior to primary procedure had significant bilateral bone loss on both the glenoid and proximal humerus.Custom glenoid was required, and fracture stem used.No further information is known.
Additional Manufacturer Narrative
(b)(4).D10 - medical product: catalog #: 110030777, +3mm lateral offset 40mm diameter glenosphere, lot # 66072614 catalog #: 110031399, mini standard thickness +0mm taper offset 40mm diameter humeral tray, lot # 66421181 catalog #: 12-113558, compr 8mm hum fract stem pps, lot # 65758088 g2: australia.H3: customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device has been requested but not returned by the hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
(b)(4).It was further discovered that the fracture was the primary issue of the event, and the dislocation was secondary.This complaint will be assessed for bone fracture.The bearing and glenosphere will be voided as they did not contribute to the reported event.
Event or Problem Description
It was further discovered that the fracture was the primary issue of the event, and the dislocation was secondary.This complaint will be assessed for bone fracture.The bearing and glenosphere will be voided as they did not contribute to the reported event.

• Brand Name: +3MM THICKNESS 40MM DIAMETER BEARING
• Common Device Name: EXTREMILTY 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: 19593784
• Report Number: 0001822565-2024-02101
• Device Sequence Number: 3980856
• Product Code: KWS
• UDI-Device Identifier: 00887868231599
• UDI-Public: (01)00887868231599(17)270928(10)65592541
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 110031428
• Device Lot Number: 65592541
• 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: 05/28/2024
• Supplement Date Received by Manufacturer: 10/01/2024
• Initial Report FDA Received Date: 06/24/2024
• Supplement Report FDA Received Date: 10/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/29/2022
• 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: Hospitalization; Required Intervention
• Patient Sex: Female