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

Model Number N/A

Device Problems Corroded (1131); Material Erosion (1214)

Patient Problem Pain (1994)

Event Date 06/08/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00801803601, femoral head sterile product do not resterilize 12/14 taper, 62246369.00630505036, liner standard 3.5 mm offset 36 mm i.D.For use with 50/52/54 mm o.D.Shells, 62237309.00625006540, bone scr 6.5x40 self-tap, 6263468.00620205222, shell porous with cluster holes 52 mm, 62214397.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 02349.Customer has indicated that the product will not be returned to zimmer biomet for investigation, not returned by patient.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the patient underwent a right hip revision approximately 7 years post implantation due to pain caused by elevated metal ions levels.Head and liner were revised.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

Reported event was unable to be confirmed.Operative notes for the initial surgery were provided and reviewed by a healthcare professional; no intraoperative complications were noted.No operative notes were provided for the revision procedure.An x-ray was submitted with this complaint.As the image is not dated, and the complaint is for revision due to metal ions, submitting an x-ray image would not enhance the investigation for metal ions, as that would require a ct/mri image.Review of the device history record for the stem identified no deviations or anomalies during manufacturing related to the reported event.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

Upon reassessment of the reported event, this report should be voided as it was determined to be a duplicate of mfr number 0001822565 - 2019 - 04851.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.Updated: b5; g3; h2.Upon reassessment of the reported event, this report should be voided as it was determined to be a duplicate of mfr number 0001822565 - 2019 - 04851.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.

• 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
• 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: 10233398
• MDR Text Key: 197732368
• Report Number: 0001822565-2020-02350
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: N/A
• Device Catalogue Number: 00771100900
• Device Lot Number: 62169769
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 79 KG