MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM FIBER METAL TAPER; PROTHESIS, HIPS

Model Number N/A

Device Problem Material Deformation (2976)

Patient Problem Failure of Implant (1924)

Event Date 08/24/2023

Event Type  Injury  

Event Description

It was reported that the patient had an initial hip surgery.Subsequently, the patient was revised fifteen (15) years post implantation due to the dislodged metal head.Head, liner, and stem were removed.Stem was removed due to deformation at the neck taper.No contributing conditions related to the event.

Manufacturer Narrative

(b)(4).D10: 00632004828 liner 20 degree elevated rim 28 mm i.D.For use with 48 mm o.D.Shell 60844833; 32902605000 femoral head 28 mm diameter medium 7 mm neck length 60946288; 65620004820 shell porous with holes 48 mm o.D.With calcicoat ceramic coating 61001146; 00625006515 bone screw self-tapping 6.5 mm dia.15 mm length 60991377; 00625006520 bone screw self-tapping 6.5 mm dia.20 mm length 60980712; 00625006520 bone screw self-tapping 6.5 mm dia.20 mm length 60980712.G2: foreign: japan.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-02654, 0001822565 - 2023 - 02655.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.

Event Description

No additional event information to report at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.Proposed component code: mechanical (g04) - stem.Visual examination of the provided pictures identified the head to have discoloration on the taper and outer rim.The liner is deformed and shows two holes which appear to be from screws to potentially remove the liner from the shell.The stem shows impingement marks on the taper and a fracture along the distal end of the stem.A review of the device history records identified no related deviations or anomalies during manufacturing.A review of complaint history found no additional related issues for this item and the reported part and lot combination.Medical records were not provided.A definitive root cause cannot be determined.The event is confirmed via provided photos.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: FEMORAL STEM FIBER METAL TAPER
• Type of Device: PROTHESIS, HIPS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17839026
• MDR Text Key: 324528139
• Report Number: 0001822565-2023-02656
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2018
• Device Model Number: N/A
• Device Catalogue Number: 65766201300
• Device Lot Number: 60938950
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2008
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Prefer Not To Disclose