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

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems Pain (1994); Metal Related Pathology (4530)

Event Date 11/06/2023

Event Type  Injury  

Event Description

It was reported that the patient underwent a revision procedure 20+ years post implantation due to pain and metallosis.There is no additional information available at the time of this report.

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports 0001825034 - 2023 - 02791, 0001825034 - 2023 - 02792.The device will not be returned for analysis as it¿s location is not known; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted h3 other text : device remains implanted.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined to be not reportable.The stem is not related to the metal related issues with the cup and head.The initial report was forwarded in error and should be voided.

Event Description

Upon reassessment of the reported event, it was determined to be not reportable.The stem is not related to the metal related issues with the cup and head.The initial report was forwarded in error and should be voided.

• Brand Name: UNKNOWN STEM
• Type of Device: PROSTHETIC, 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: 18226530
• MDR Text Key: 329205111
• Report Number: 0001825034-2023-02800
• Device Sequence Number: 1
• Product Code: LPH
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/09/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• 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
• Initial Date Manufacturer Received: 11/06/2023
• Initial Date FDA Received: 11/29/2023
• Supplement Dates Manufacturer Received: 01/08/2024
• Supplement Dates FDA Received: 01/10/2024
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNKNOWN MAGNUM CUP, UNKNOWN HEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male