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

Model Number N/A

Device Problem Corroded (1131)

Patient Problems Host-Tissue Reaction (1297); Pain (1994); Metal Related Pathology (4530)

Event Date 12/02/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Item# unknown liner lot# unknown.Item# unknown stem lot# unknown.Item# 00801803201 femoral head lot# 60975943.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: 0002648920 -2019 -00899.

Event Description

It was reported that patient underwent total hip arthroplasty on unknown date.Patient was revised due to alval/corrosion/pain.No further information available.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Updated: b4, b5, g4, h2, h3, h6 reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.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.

Event Description

It was reported the patient underwent left total hip arthroplasty.Subsequently revision was performed approximately 11 years later due to pain, elevated metal ions and corrosion.Femoral head was revised.No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D10: cat# 00620205422 shell porous with cluster holes 54 mm lot#60961728.Cat# 00631005032 liner 10 degree elevated rim 32 mm i.D.For use with 50/52/54 mm o.D.Shells lot#60866550.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Medical records were provided and reviewed by a healthcare professional.Patient was revised due to pain, elevated metal ions and corrosion.Labs taken before revision identified elevated cobalt levels along with normal sed rate and crp.During revision, capsule was thickened but not to degree that would expect with altr.There was staining of the trunnion that was cleaned.Tan staining to liner however decided to retain.Femoral head was exchanged.No other complications noted.Review of the device history records identified no deviations or anomalies during manufacturing.Additional information provided does not change the root cause of the previous investigation.A definitive root cause cannot 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: 9476266
• MDR Text Key: 172560403
• Report Number: 0001822565-2019-05314
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• PMA/PMN Number: K192660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Model Number: N/A
• Device Catalogue Number: 00771100700
• Device Lot Number: 60894782
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/04/2021
• 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 Age: 53 YR
• Patient Weight: 96