MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP LK SCR 3.5HEX 4.75X35 ST; PROSTHESIS, SHOULDER

Model Number 180554

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/23/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Foreign source: uk.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was 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.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

It was reported that during a comprehensive reverse shoulder replacement one of the locking peripheral screws fractured while being implanted into the patient.On backing the screw out, it sheered off the head of the screw.The remaining part of the screw was not able to be removed and was secured in the glenoid behind the baseplate.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h1, h2, h3, h6, h10 reported event was confirmed by review of pictures.Visual examination of the provided pictures identified the screw has fractured a couple threads below the screw head.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to 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 is available at the time of this report.

• Brand Name: COMP LK SCR 3.5HEX 4.75X35 ST
• Type of Device: PROSTHESIS, SHOULDER
• 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: 15337132
• MDR Text Key: 299077608
• Report Number: 0001825034-2022-01990
• Device Sequence Number: 1
• Product Code: MBF
• UDI-Device Identifier: 00880304677173
• UDI-Public: (01)00880304677173(17)311222(10)161040
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K130390
• 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: 10/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 180554
• Device Catalogue Number: 180554
• Device Lot Number: 161040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/22/2021
• 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
• Treatment: CAT: 010000589 COMP RVRS 25MM BSPLT HA+ADPTR R
• Patient Outcome(s): Required Intervention