MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE SHOULDER SYSTEM STANDARD TAPER ADAPTOR; EXTREMITIES - IMPLANT

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Failure of Implant (1924); Insufficient Information (4580)

Event Date 09/06/2023

Event Type  Injury  

Event Description

It was reported the patient was revised a second time approximately 2 months ago due to disassociation.At that time the baseplate and screws were taken out along with the taper and glenosphere.Attempts have been made and there is no further information at this time.

Manufacturer Narrative

(b)(4).D10 - medical product: catalog #: 115330, comp rvrs shdr glen bsplt +ha, lot # 245740.Catalog #: 180552, comp lk scr 3.5hex 4.75x25 st, lot # 66008638.Catalog #: 180550, comp lk scr 3.5hex 4.75x15 st, lot # 66077441.Catalog #: 180552, comp lk scr 3.5hex 4.75x25 st, lot # 66058947.Catalog #: 180551, comp lk scr 3.5hex 4.75x20 st, lot # 66071785.H3: product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-02643.

• Brand Name: COMPREHENSIVE SHOULDER SYSTEM STANDARD TAPER ADAPTOR
• Type of Device: EXTREMITIES - IMPLANT
• 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: 18118674
• MDR Text Key: 327912412
• Report Number: 0001825034-2023-02646
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 00880304217249
• UDI-Public: (01)00880304217249(17)330717(10)J7569385
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060716
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 118001
• Device Lot Number: J7569385
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Male