MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM 12/14 NECK TAPER CEMENTLESS SIZE 7.5 STANDARD OFFSET; PROSTHESIS, HIP

Model Number N/A

Device Problems Corroded (1131); Material Erosion (1214); Unstable (1667)

Patient Problems Necrosis (1971); Osteolysis (2377); Metal Related Pathology (4530); Muscle/Tendon Damage (4532)

Event Date 10/19/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device will not be returned for analysis, as the device remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0002648920 - 2021 - 00327.

Event Description

It was reported that the patient underwent initial right total hip arthroplasty.Subsequently, the patient was revised approximately 5 years later due to instability.During the revision, extensive bone and tissue necrosis was noted with resorption of the ilium and femur.Minor corrosion was noted on the trunnion as the femoral head was removed.The stem was stable and left intact, all other components were replaced without complication.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

This follow-up report is being submitted to relay additional information.The following sections were {update/corrected} updated: a1, a3, a4, b7.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: a revision occurred due to instability.Upon entering the joint, necrosis was found and very little of the abductor was intact and viable.The femoral component was stable and retained.Corrosion was noted on the trunnion.The shell was removed so a constrained liner could be placed.New components were placed without complication.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.

• Brand Name: FEMORAL STEM 12/14 NECK TAPER CEMENTLESS SIZE 7.5 STANDARD OFFSET
• 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: 12591320
• MDR Text Key: 275206948
• Report Number: 0001822565-2021-02923
• Device Sequence Number: 1
• Product Code: MEH
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/05/2022

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 Model Number: N/A
• Device Catalogue Number: 00771100710
• Device Lot Number: 62727817
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: ZIMMER LINER CAT#00630504832 LOT 62731090; ZIMMER TM SHELL CAT#00620204820 LOT 62898735; ZIMMER LINER CAT#00630504832 LOT 62731090; ZIMMER TM SHELL CAT#00620204820 LOT 62898735
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 84 KG