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 Problems Ossification (1428); Failure of Implant (1924); Inflammation (1932); Pain (1994); Osteolysis (2377); Ambulation Difficulties (2544); Metal Related Pathology (4530); Muscle/Tendon Damage (4532)

Event Date 02/02/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00801803202- femoral head sterile product do not resterilize 12/14 taper-60988023; 00620005622-shell porous with cluster holes 56 mm o.D.- 60947319; 00625006535-bone screw self-tapping 6.5 mm dia.35 mm length-60952882; 00625006540-bone screw self-tapping 6.5 mm dia.40 mm length-60918150.Multiple mdr reports were filed for this event, please see associated reports: 0002648920 - 2021 - 00324.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 right hip revision approximately 13 years post implantation due to pain, bursitis, limp, elevated metal ions.During the procedure the surgeon reported altr, pseudotumor, metallosis, with corrosion and muscle tendon ruptures.Head and liner were exchanged without complications.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: g3; h2; h3; h4; h6.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 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

No additional information on the reported event.

• 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: 12593019
• MDR Text Key: 275275718
• Report Number: 0001822565-2021-02908
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/18/2022

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: 11/30/2017
• Device Model Number: N/A
• Device Catalogue Number: 00771101500
• Device Lot Number: 60819299
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2007
• 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: Male
• Patient Weight: 86 KG