MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK CUP; PROSTHESIS, HIP

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems Pain (1994); Metal Related Pathology (4530); Muscle/Tendon Damage (4532)

Event Date 06/15/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2024 - 00432; 0001825034 - 2024 - 00433; 0001825034 - 2024 - 00434.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Complaint confirmed based on the evaluation of the medical records.Part and lot identification are necessary for review of device history records, neither were provided.Medical records were provided and identified the following: extensive soft tissue damage and debris from metal wear, 90% of abductors chronically torn and damaged.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.

Event Description

It was reported that the patient underwent a revision approximately eighteen years post implantation due to pain, metal artifact, fluid collection, and tendon tears.During the procedure, extensive soft tissue damage, debris from metal wear, and torn/damaged abductors were noted.The cup, head, and liner were exchanged without complication.The stem remained implanted.Attempts have been made and no further information has been provided.

• Brand Name: UNK CUP
• 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: 18747184
• MDR Text Key: 335869861
• Report Number: 0001825034-2024-00431
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2024
• 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
• Date Manufacturer Received: 01/31/2024
• 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): Required Intervention; Hospitalization
• Patient Sex: Male