MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN 38 ACETABULAR CUP; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Cyst(s) (1800); Pain (1994); Reaction (2414)

Event Date 10/19/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.Concomitant medical products: item number: unknown, item name: unknown m2a 38 femoral head, lot #: unknown, item number: unknown, item name: unknown stem, lot #: unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 09494.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported patient underwent right hip arthroplasty approximately 9 years post-implantation due to pain and metallosis.A cyst was observed and debrided during revision surgery, this was found to be consistent with metallosis.Attempts have been made and no additional information is available.

Event Description

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

Manufacturer Narrative

Upon receipt of additional information, it has been determined that this device did not cause or contribute to the reported event.The initial report was forwarded in error and should be voided.

• Brand Name: UNKNOWN 38 ACETABULAR CUP
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7944947
• MDR Text Key: 123059676
• Report Number: 0001825034-2018-09495
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 01/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/10/2018
• 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