MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 28MM DIA COCR MOD HD +12MM NK; PROSTHESIS, HIP

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Failure of Implant (1924)

Event Date 04/29/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues: subluxation/dislocation of the left hip arthroplasty with marked abnormal vertical cup orientation as noted.A review of the device history records identified no related deviations or anomalies during manufacturing.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 - 02437.

Event Description

It was reported that patient underwent a second left hip revision approximately 6 weeks after the previous due to dislocation and finding the bearing had popped off the head component.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: 28MM DIA COCR MOD HD +12MM NK
• 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: 15690362
• MDR Text Key: 302577422
• Report Number: 0001825034-2022-02438
• Device Sequence Number: 1
• Product Code: JDG
• UDI-Device Identifier: 00887868308307
• UDI-Public: (01)00887868308307(17)301119(10)457960
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K983710
• 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
• Report Date: 10/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2022
• 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: 163666
• Device Lot Number: 457960
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2020
• 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: UNK CUP; UNK STEM
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female