MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN HEAD; PROSTHETIC, HIP

Model Number N/A

Device Problem Naturally Worn (2988)

Patient Problems Adhesion(s) (1695); Pain (1994); Scar Tissue (2060); Osteolysis (2377); Metal Related Pathology (4530)

Event Date 12/02/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: pain, debris from metallosis, scar tissue and adhesions debrided, acetabular gross loosening and inverted 180 degrees, unable to remove taper/head due to cold weld, noted bone insufficiency from osteolysis, no complications.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 - 2021 - 02085, 0001825034 - 2021 - 02084, 0001825034 - 2021 - 02083.

Event Description

It was reported by legal, patient underwent left tha.Subsequently left tha revision was performed ten (10) years later due to pain, loosening and metallosis.All components removed.No further event information available at the time of this report.

• Brand Name: UNKNOWN HEAD
• Type of Device: PROSTHETIC, 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: 12162978
• MDR Text Key: 261436233
• Report Number: 0001825034-2021-02086
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/28/2021
• 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
• Patient Outcome(s): Hospitalization; Required Intervention