MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM PF CUP 52ODX46ID; PROSTHESIS, HIP

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems Cyst(s) (1800); Unspecified Infection (1930); Pain (1994); Sepsis (2067); Urinary Tract Infection (2120); Hip Fracture (2349); Numbness (2415); Blood Loss (2597); Fluid Discharge (2686)

Event Date 06/11/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of event ¿ (b)(6) 2018.Medical devices: 157446 ¿ m2a magnum head ¿ 983620; 15-103203 ¿ taperloc femoral stem ¿ 571490; 139252 ¿ m2a magnum insert ¿ 615460; therapy date: (b)(6) 2018.Customer has indicated that the product will not be returned to zimmer biomet for investigation as production location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 00209, 0001825034 - 2019 - 00210, 0001825034 - 2019 - 00211.

Event Description

It was reported that patient began experiencing clicking noise post implantation.Approximately 7 years post initial implantation, patient was hospitalized for kidney stone, uti, sepsis, significant pain, and numbness.Approximately 3 months later, x-rays, an mri, and blood test showed bone loss in hip and femur around implant, large fluid filled pseudo-cyst, and high chromium ion levels.A week prior to revision surgery, patient experienced continuous draining of pink/tan mucous-like fluid.The patient underwent the first stage of a two-stage revision where implants were removed.During the surgery, the femur was cut in order to remove the stem component and wired back together along with a cement spacer installed and six weeks of iv antibiotics were given for bone infection.Installation of permanent implants has not been reported to date.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

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 during the first stage revision, the patient had an estimated blood loss of 2800 ml and required a blood transfusion.Attempts have been made and no further information has been provided.

Event Description

The permanent devices were implanted approximately 10 weeks after the first stage of the revision.

Manufacturer Narrative

Report source: mw5082423.This follow-up report is being submitted to relay additional information.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed via medical records.Dhr was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to 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

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

• Brand Name: M2A-MAGNUM PF CUP 52ODX46ID
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8256202
• MDR Text Key: 133321187
• Report Number: 0001825034-2019-00208
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K042037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2020
• Device Model Number: N/A
• Device Catalogue Number: US157852
• Device Lot Number: 849260
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/02/2019
• 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
• Patient Weight: 120