MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SHELL POROUS WITH CLUSTER HOLES 62 MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Unintended Movement (3026)

Patient Problems Pain (1994); Unspecified Tissue Injury (4559)

Event Date 01/05/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00801803602-femoral head sterile, product do not resterilize, 12/14 taper-61687775.00630506236-liner standard 3.5 mm offset 36 mm i.D.For use with 62 mm o.D.Shell-61436931.00771100900-femoral stem 12/14 neck taper plasma sprayed press-fit cementless size 9 standard offset-61652411.00625006520-bone screw self-tapping 6.5 mm dia.20 mm length-60892261.00625006530-bone screw self-tapping 6.5 mm dia.30 mm length-61504843.Multiple mdr reports were filed for this event, please see associated reports: 0002648920 -2021-00322.0001822565-2021-02893.0001822565-2021-02894.Customer has indicated that the product will not be returned to zimmer biomet for investigation, product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device remains implanted.

Event Description

It was reported patient underwent a left hip revision approximately 7 years post implantation due to having recurrent dislocations, pain, and elevated metal ions.During the procedure significant metallosis, necrotic tissue, and synovial inflammation was debrided.A new head, liner, and locking ring was placed without complication.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

No additional information on the reported event.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: reported event was confirmed via medical records reviewed by a health care professional.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.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.

• Brand Name: SHELL POROUS WITH CLUSTER HOLES 62 MM
• 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: 12591794
• MDR Text Key: 275226700
• Report Number: 0001822565-2021-02895
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021891
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2014
• Device Model Number: N/A
• Device Catalogue Number: 00620206222
• Device Lot Number: 60235114
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2004
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White