MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVRS 25MM BSPLT HA+ADPTR; SHOULDER, PROSTHESIS

Catalog Number 010000589

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Joint Dislocation (2374)

Event Date 03/26/2024

Event Type  Injury  

Event Description

It was reported that the patient was revised due to implant disassociation approximately ten days post implantation.No additional patient consequences were reported.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).D10: comp rvrs shldr glnsp std 36mm cat: 115310 lot: j7575224.Comp lk scr 3.5hex 4.75x20 st cat: 180551 lot: 66300811.Comp primary stem 5mm micro cat: 113605 lot: 478220.Mini tray std cocr +6 offset cat: 110031405 lot: 66555227.Cr vivacit-e 36mm brng +3 cat: 110031425 lot: 65809017.Comp lk scr 3.5hex 4.75x20 st cat: 180551 lot: 66098085.Comp rvs cntrl 6.5x25mm st/rst cat: 115395 lot: 66391536.G2: foreign: australia.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 report will be submitted.

• Brand Name: COMP RVRS 25MM BSPLT HA+ADPTR
• Type of Device: SHOULDER, PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19154634
• MDR Text Key: 340735772
• Report Number: 0001825034-2024-01056
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00880304532465
• UDI-Public: (01)00880304532465(17)331011(10)66027176
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K193373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/22/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 010000589
• Device Lot Number: 66027176
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/28/2024
• Initial Date FDA Received: 04/22/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/11/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 70 KG