MAUDE Adverse Event Report: ZIMMER BIOMET, INC. METASULA STANDARD INSERT SIZE 28MM X 65MM; PROSTHESIS, HIP

Model Number N/A

Device Problems Material Erosion (1214); Unstable (1667); Device Dislodged or Dislocated (2923)

Patient Problems Local Reaction (2035); Joint Dislocation (2374); Osteolysis (2377)

Event Date 03/15/2010

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 734028000 neutral neck use with 12/14 1340034.7354-02-207 schaft nh m/kragen 12/14 7 r 1192728.4360-00-065 hemis por shell w/sealed 1367353.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The product 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: 0001822565 - 2020 - 02882.

Event Description

It was reported patient underwent right hip revision approximately ten years post implantation on due to pain and implant failure.The patient was revised again on twenty years later due to dislocation, recurrent instability and mechanical loosening of joint due to poly wear.During the procedure, reactive soft tissue changes presumably from third body wear, was noted, osteolysis of the greater trochanter was noted.The head and liner were removed and replaced.No additional information is available.

Manufacturer Narrative

(b)(4).Reported event was confirmed by review of medical records.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.Medical records identified the following : the patient underwent an initial right total hip arthroplasty on an unknown date.The patient was revised due to failed painful right total hip arthroplasty, during when zimmer biomet components were implanted.The patient was revised again due to failed hip arthroplasty.There was dislocation of the prosthetic joint.The patient had underwent 3 hip surgeries with subsequent instability and multiple dislocations prior to the procedure.Reactive soft tissue changes presumably from third body wear.Soft tissue reactive changes involving essentially dissolving the entire trochanter of the right hip and associated soft tissue muscles.The stem showed areas of erosion proximally.The stem and cup were well fixed.Liner and head were replaced with new zimmer biomet products.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.

• Brand Name: METASULA STANDARD INSERT SIZE 28MM X 65MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10395479
• MDR Text Key: 202522405
• Report Number: 0001822565-2020-02880
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K974728
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 12/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 437228065
• Device Lot Number: 1330661
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/25/2020
• 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