MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN INSERTER; INSTRUMENTS, HIPS

Model Number N/A

Device Problems Separation Failure (2547); Material Integrity Problem (2978)

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

Event Date 07/13/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).D10: unknown cup unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2023 - 01834.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the g7 straight inserter for the g7 cup malfunctioned in the patient.The g7 cup implant would not thread off the straight inserter.The cup had to be removed and a new cup was opened and used.There was a 10¿15-minute delay.No known impact or consequence to the patient.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.No product was returned; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.Complaint history review cannot be performed without product identification.Medical records were not provided.Unable to confirm complaint.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No additional event information to report at this time.

• Brand Name: UNKNOWN INSERTER
• Type of Device: INSTRUMENTS, HIPS
• 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: 17470903
• MDR Text Key: 320524524
• Report Number: 0001825034-2023-01833
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN INSERTER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Age: 50 YR
• Patient Sex: Male