MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN 36 -3 CERAMIC BIOLOX; PROSTHESIS, HIP

Model Number N/A

Device Problem Noise, Audible (3273)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/17/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant products: unknown g7 ve liner, unknown cup, unknown stem.Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to 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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2021 - 02647.

Event Description

It was reported patient underwent initial hip arthroplasty on unknown date.Subsequently the patient was revised due to noise of the hip.X-rays and an ultrasound were taken, and nothing was shown to be dislocated.Implants were in good positions.During pre op, the surgeon went through several range of motion tests and the hip did not dislocate, but there was a small click which the surgeon determined was tightness in the it band.The head and liner were removed and replaced.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

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

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.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

Upon reassessment of the reported event, it was determined to be not reportable.This will be reported under the correct mfr number on 3002806535-2021-00441.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined to be not reportable.This will be reported under the correct mfr number on 3002806535-2021-00441.

• Brand Name: UNKNOWN 36 -3 CERAMIC BIOLOX
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12467136
• MDR Text Key: 271261968
• Report Number: 0001825034-2021-02648
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 10/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention