MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SELEX/MAGNUM MOD HD 40MM -6; PROSTHESIS, HIP

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems Necrosis (1971); Pain (1994); Local Reaction (2035); Scar Tissue (2060)

Event Date 12/03/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: us257846 644220 magnum trispike cup 46odx40id 0mm 11-103204 930670 taperloc por fmrl lat 10x140.Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the location of the device 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: 0001825034-2021-02631, 0001825034-2021-02634.

Event Description

It was reported patient underwent initial hip arthroplasty.Subsequently, the patient was revised approximately 10 years post implantation due to pain and elevated metal ions.During the revision, pseudocapsule, necrosis, scar tissue, and metallosis were debrided.Implant wear was noted at the trunnion.The initial head was replaced with a dual mobility construct without complication.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Reported event was confirmed, by review of medical records received.Review of the available records, identified the patient was revised, due to pain and elevated metal ions.Painful mom tha with elevated cobalt and chromium levels.Disruption and scarring of the abductors noted.Pseudocapsule, necrotic material and metallosis debrided.Wear noted, at the trunnion, but unsure if corroded.Head was revised with ceramic head and poly liner.The device history record (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 report 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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.H6: component code: mechanical (g04) - head.A selex/magnum mod hd 40mm -6, part # s061140 from lot 570640, was returned and evaluated against the complaint.Visual inspection found dark greenish debris within the taper of the head.The heads outer radius is scuffed and scratched in multiple locations.The additional information does not change the outcome of the previous investigation.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: SELEX/MAGNUM MOD HD 40MM -6
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12446558
• MDR Text Key: 270529243
• Report Number: 0001825034-2021-02633
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062997
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: N/A
• Device Catalogue Number: S061140
• Device Lot Number: 570640
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2010
• 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): Hospitalization; Required Intervention
• Patient Sex: Female