MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZB TYPE 1 CERAMIC HD 40MM X +6; PROSTHESIS, HIP

Model Number N/A

Device Problem Off-Label Use (1494)

Patient Problem Bone Fracture(s) (1870)

Event Date 01/23/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Proposed component code: mechanical (g04) - head.Concomitant medical products: cat#: 193014 echo b-mtrc mp fp so 14, lot#: 326560.Cat#: 30104008 g7 vit e neutral lnr 40mm h, lot#: 65502248.Unknown shell.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing.Medical records were not provided.It was identified that the head and stem are not compatible, however it is unknown if the off label usage caused or contributed to the reported event.A definitive root cause could not 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.

Event Description

It was reported the patient had post-op periprosthetic fracture of femur requiring revision approximately 12 (twelve) days after initial surgery.This revision was not due to a fall.It is noted that the head is not compatible with the stem.

• Brand Name: ZB TYPE 1 CERAMIC HD 40MM X +6
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16362269
• MDR Text Key: 309382410
• Report Number: 0001822565-2023-00302
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 00887868376702
• UDI-Public: (01)00887868376702(17)320211(10)3095459
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200823
• 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: 02/02/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 802804004
• Device Lot Number: 3095459
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/23/2023
• Initial Date FDA Received: 02/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2022
• 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 Sex: Male