MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 32MM MOD HEAD COCR -3MM NECK; PROSTHESIS, HIP

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Fall (1848); Joint Dislocation (2374)

Event Date 10/01/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10: cat#010000850 lot#6489079 liner, cat#51-113140 lot#6537103 stem, cat#110010266 lot#6463340 shell.G2: foreign: country: australia h6: proposed component code: mechanical (g04)- head.Reported event was unable to be confirmed due to limited information received from the customer.Radiographs provided were taken 3 months before the dislocation and were not assessed.Device history record (dhr) was reviewed and no discrepancies were found.It was reported the patient dislocated due to a fall.As the reason for the fall is unknown, a definitive root cause cannot 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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-02421.

Event Description

It was reported the patient underwent a hip revision approximately 3 years post implantation due to a fall causing a dislocation.No additional information.

• Brand Name: 32MM MOD HEAD COCR -3MM NECK
• Type of Device: PROSTHESIS, HIP
• 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: 16784217
• MDR Text Key: 313717179
• Report Number: 0001825034-2023-00888
• Device Sequence Number: 1
• Product Code: JDG
• UDI-Device Identifier: 00887868308321
• UDI-Public: (01)00887868308321(17)290626(10)64449451
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K942479
• 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
• Report Date: 04/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 163668
• Device Lot Number: 64449451
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/20/2023
• Initial Date FDA Received: 04/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 86 KG