MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SIRIUS HIP STEM 44-D; PROSTHESIS, HIP

Model Number N/A

Device Problems Loss of or Failure to Bond (1068); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cyst(s) (1800); Failure of Implant (1924); Osteolysis (2377)

Event Date 05/13/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 11-363662 36mm cocr mod hd std 642860; 131360 exc abt rnglc-x shell pc 060mm 3241538; xl-053660 rloc-x arcomxl h/w 60/36mm 26 32226888.Report source: foreign source - (b)(6).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 patient experienced osteolysis, fluid, and cyst approximately 5 years post initial implantation.Attempts were made to obtain additional information; however, none was available.

Manufacturer Narrative

Reported event was confirmed by review of medical records.Review of the medical records identified that the patient had a cyst and fluid on the hip with osteolysis, found on mri imaging.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 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

Reported event was confirmed by review of medical records noting severe osteolysis in distal part of the femur surrounding the stem.Large cyst under the femur prosthesis.Thin bone was noted.The right stem aseptic loosening due to severe osteolysis.Additional information does not change the previous investigation results.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 patient presented to physician approximately 5 years post initial right hip total arthroplasty where osteolysis was found along with fluid and cyst near the stem.Approximately 18 months later, it was noted that the osteolysis had progressed and the stem component had become loose.The patient underwent a revision surgery to remove the loose stem.Attempts have been made and no additional event information is available at this time.

• Brand Name: SIRIUS HIP STEM 44-D
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8823591
• MDR Text Key: 152103995
• Report Number: 0001825034-2019-03118
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: K130610
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 06/24/2021

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 Expiration Date: 04/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 51-199341
• Device Lot Number: 173010
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/01/2019
• Initial Date FDA Received: 07/24/2019
• Supplement Dates Manufacturer Received: 10/01/2019; 06/08/2021
• Supplement Dates FDA Received: 10/07/2019; 06/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 71 YR
• Patient Weight: 80