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

Model Number N/A

Device Problems Material Erosion (1214); Noise, Audible (3273)

Patient Problems Hip Fracture (2349); Reaction (2414)

Event Date 02/17/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Unknown head,pn unknown, ln unknown.Multiple mdr reports were filed for this event.Please see reports: 0001825034-2018-11083.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent a revision surgery due to metallosis, elevated ion levels, pain, bone loss, bone fracture, tissue damage, approximately 10 years after the initial surgery.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

Upon receipt of additional information, it has been determined this report is a duplicate of the event reported under 0001825034-2016-02619.The initial report was forwarded in error and should be voided.If additional information regarding this event is received, a supplemental report will be filed under 0001825034-2016-02619.

• Brand Name: UNKNOWN CUP
• Type of Device: PROSTHESIS HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8146941
• MDR Text Key: 129789922
• Report Number: 0001825034-2018-11082
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 01/04/2019

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?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/14/2018
• Initial Date FDA Received: 12/10/2018
• Supplement Dates Manufacturer Received: 01/04/2019
• Supplement Dates FDA Received: 02/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention