MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP PRIMARY STEM 12MM MICRO; PROSTHESIS, SHOULDER

Catalog Number 113612

Device Problem Difficult to Insert (1316)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/26/2024

Event Type  malfunction  

Event Description

It was reported that the surgeon was having issues with the implant not sitting on the bone.The surgeon re-surfaced the bone so it would sit without the gap.No adverse event has been reported as a result of the malfunction.

Manufacturer Narrative

(b)(4).G2: foreign- australia customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.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.

Manufacturer Narrative

Proposed annex g code: mechanical (g04) - stem.Reported event was unable to be confirmed due to limited information received from the customer.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Device is used for treatment.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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 PRIMARY STEM 12MM MICRO
• 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: 18911660
• MDR Text Key: 337742470
• Report Number: 0001825034-2024-00659
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 00887868267628
• UDI-Public: (01)00887868267628(17)330708(10)65886103
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 06/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 113612
• Device Lot Number: 65886103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/26/2024
• Initial Date FDA Received: 03/15/2024
• Supplement Dates Manufacturer Received: 06/17/2024
• Supplement Dates FDA Received: 06/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2023
• 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