MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN ZB FEMORAL STEM; PROTHESIS, HIPS

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Necrosis (1971); Pain (1994); Ambulation Difficulties (2544); Unequal Limb Length (4534)

Event Date 11/03/2023

Event Type  Injury  

Event Description

It was reported initial left total hip arthroplasty on unknown date.Subsequently, revised due to pain, severe difficulty ambulating, severe difficulty with adls, avascular necrosis, leg length discrepancy and dislocation.All components exchanged without complications.No operative record provided.

Manufacturer Narrative

(b)(4).D10: unk zb acetabular shell ; unk zb screw ; unk zb femoral head; unk zb acetabular liner.G2: foreign: south korea.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-03249; 0001822565 -2023 -03250; 0001822565-2023-03251; 0001822565-2023-03254.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

No additional event information to report at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.Proposed component code: mechanical (g04)- stem.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.Complaint history review cannot be performed without product identification.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: an initial left tha was performed on an unknown date.A revision occurred due to pain, severe problems walking and doing usual activities, and dislocation.It was identified there was a limb length discrepancy on the left side as well.All devices were explanted and replaced with zb product.A definitive root cause cannot be determined.No problem was found with the devices related to the avn, as it was determined to be unrelated to the devices by a healthcare professional.This complaint was confirmed based on the provided medical records.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: UNKNOWN ZB FEMORAL STEM
• Type of Device: PROTHESIS, HIPS
• 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: 18156642
• MDR Text Key: 328351369
• Report Number: 0001822565-2023-03253
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/09/2024

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: UNK ZB FEMORAL STEM
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/07/2023
• Initial Date FDA Received: 11/16/2023
• Supplement Dates Manufacturer Received: 01/08/2024
• Supplement Dates FDA Received: 01/09/2024
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 59 KG
• Patient Race: Asian