MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE REVERSE SHOULDER STEM MINI; EXTREMITY IMPLANT

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 10/19/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).G2: spain.D10 - medical product: catalog #: 010000589, comp rvrs 25mm bsplt ha+adptr, lot # 104660.Catalog #: 115310, comp rvrs shldr glnsp std 36mm, lot # j7336441.Catalog #: xl-115363, arcom xl 44-36 std hmrl brng, lot # 895350.Catalog #: 115375, comp rvs tray +5mm co 44mm, lot # 931240.H3: customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device has been requested by hospital but not returned.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: 0001825034-2023-02548, 0001825034-2023-02550, 0001825034-2023-02551, 0001825034-2023-02553 h3 other text : requested by hospital but not returned.

Event Description

It was reported that the patient had initial surgery approximately 10 months ago.Subsequently, they had a revision approximately 9 months post-implantation for unknown reasons.It was stated that the patient did not follow the surgeon's instructions and that the patient did not have an infection.There was no contributing condition and the revision went according to plan.Attempts have been made and there is no further information at this time.

Manufacturer Narrative

(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies relevant to the reported event were found.Patient non-compliance to surgeon's instructions was noted.However, with the information available a definitive root cause cannot 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.

Event Description

No further event information available at the time of this report.

• Brand Name: COMPREHENSIVE REVERSE SHOULDER STEM MINI
• Type of Device: EXTREMITY 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: 18050340
• MDR Text Key: 327128179
• Report Number: 0001825034-2023-02552
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 00880304449756
• UDI-Public: (01)00880304449756(17)271130(10)65641630
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K060692
• 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,Followup
• Report Date: 04/30/2024

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 113628
• Device Lot Number: 65641630
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/19/2023
• Initial Date FDA Received: 11/01/2023
• Supplement Dates Manufacturer Received: 04/25/2024
• Supplement Dates FDA Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2022
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female