MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN SCREW; SHOULDER, PROSTHESIS

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 10/27/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-03637, 0001822565-2023-03638, 0001822565-2023-03639.D10: unk poly +6, unk tray, unk glenosphere, unk stem, unk baseplate.It is unknown if product will be returning to zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.H3 other text : product not returned.

Event Description

It was reported that the patient was revised due to infection approximately seven weeks post initial procedure.No additional patient consequences were reported.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Mulltiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-03638, 0001822565-2023-03639, 0001822565-2023-03637, 0001825034-2024-00757, 0001825034-2024-00756, 0001825034-2024-00755, 0001825034-2024-00752, 0001825034-2024-00750.D10: cr vivacit-e 36mm brng +3 cat: 110031425 lot: 65809012, mini tray std cocr +6 offset cat: 110031405 lot: 66100902, comp rvrs shldr glnsp std 36mm cat: 115310 lot: j7531733, comp lk scr 3.5hex 4.75x15 st cat: 180550 lot: 66177946, comp lk scr 3.5hex 4.75x30 st cat: 180553 lot: 66098120, comp lk scr 3.5hex 4.75x15 st cat: 180550 lot: 66008607, comp rvs cntrl 6.5x40mm st/rst cat: 115398 lot: 65962140, comp lk scr 3.5hex 4.75x20 st cat: 180551 lot: 66021321, 25mm versa-dial taper adaptor cat: 118000 lot: j7217167, unknown stem, unknown baseplate.As product id was received and sterile certs were reviewed, this event will be considered not reportable.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: UNKNOWN SCREW
• Type of Device: SHOULDER, PROSTHESIS
• 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: 18327693
• MDR Text Key: 330506693
• Report Number: 0001822565-2023-03640
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130390
• 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
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2023
• 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
• Treatment: SEE H10; SEE H10
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 100 KG