MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED; PROSTHESIS, HIP

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems Erosion (1750); Pain (1994); Local Reaction (2035)

Event Date 05/13/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: cat# 00875705801 shell with cluster holes porous lot# unk; cat# 00877001340 metasul taper liner ll/40 lot#unk; cat# 00877004003 metasul head 40, 12/14, size l /+3.5 lot#unk.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 03374.

Event Description

It was reported patient¿s legal counsel reported patient underwent right hip revision approximately 5 years post implantation due to patient allegations of pain, elevated metal ion levels.Operative records received show altr and bone erosions around the well ¿ fixed femoral and acetabular components.The head and liner were revised.No additional information.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: the patient underwent an initial right total hip arthroplasty due to degenerative joint disease.Zimmer biomet components were implanted without any complications.The patient was revised due to failed hip arthroplasty.During the procedure, yellow turbid non purulent fluid was encountered.Adverse tissue reaction material had eroded along the very proximal aspect of the bone-prosthetic interface of the proximal femoral stem.The acetabular cup was well fixed with small erosions of adverse tissue reaction around the margin.The head and liner were replaced.No other findings/complications related to the reported event were noted.Device history record (dhr) was reviewed and no discrepancies 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: FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10605272
• MDR Text Key: 209129197
• Report Number: 0001822565-2020-03379
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K161830
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 10/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Model Number: N/A
• Device Catalogue Number: 00771100900
• Device Lot Number: 61356526
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention