MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZB 12/14 COCR FRDM 32MM X +3; PROSTHESIS, HIP

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Fall (1848); Necrosis (1971); Joint Dislocation (2374)

Event Date 11/19/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant products: 010000980 3929945 g7 freedom const e1 lnr 32mm b; 110010261 6952447 g7 osseoti multihole 46mm b; competitor polar femoral component.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 - 03272.

Event Description

It was reported patient underwent right hemiarthroplasty to repair a femoral neck fracture.Subsequently 3 dislocations occurred resulting in conversion to right total hip arthroplasty approximately 3 moths post right hemiarthroplasty.Patient sustained a fall approximately 6 weeks post op that resulted in a dislocation and 2 additional dislocations occurred post reduction.Revision performed approximately 3 months post tha with removal of head/liner, and competitor stem.Surgeon noted necrosis of capsule and well-fixed acetabulum.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined to be not reportable.This will be reported under a mfr number 0001822565 - 2022 - 00023.

Event Description

Upon reassessment of the reported event, it was determined to be not reportable.This will be reported under a mfr number 0001822565 - 2022 - 00023.

• Brand Name: ZB 12/14 COCR FRDM 32MM X +3
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13049688
• MDR Text Key: 282554690
• Report Number: 0001825034-2021-03271
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183457
• 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: 01/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• 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: 802403203
• Device Lot Number: 3036163
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/31/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 48 KG