MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM BEADED FULLCOAT 12/14 NECK TAPER STD. BODY; PROSTHESIS, HIP

Model Number N/A

Device Problems Unstable (1667); Detachment of Device or Device Component (2907)

Patient Problems Fall (1848); Hematoma (1884); Pain (1994); Scar Tissue (2060); Osteopenia/ Osteoporosis (2651); Swelling/ Edema (4577)

Event Date 09/23/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: 00-8777-032-04 biolox delta option fem head, 32mm, +7mm lot#3016713; 00-6202-054-22 tm modular cup 54mm cluster-hole lot#60116440; 00-6250-065-40 bone screw 6.5x40 selftap lot#60097476; 00-6250-065-40 bone screw 6.5x40 selftap lot#60124936.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 - 00365.

Event Description

It was reported the patient underwent initial left total hip arthroplasty.Subsequently the patient was revised a second time due to dislocation and dissociated femoral head from falling off step approximately 17 years after the initial tha.During the revision a hematoma, swelling, scar tissue, inaccessible femoral head, and bone loss were noted.The head, cup, liner, and screws 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.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: the patient was revised for dislocation and the head dissociating from the trunnion.A hematoma was noted upon entry into the joint.The shell and liner had to be removed to access the femoral head.Zimmer products were implanted and range of motion was good.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 further event information available at the time of this report.

• Brand Name: FEMORAL STEM BEADED FULLCOAT 12/14 NECK TAPER STD. BODY
• 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: 12688887
• MDR Text Key: 278117164
• Report Number: 0001822565-2021-03098
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K953337
• 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
• Report Date: 01/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2013
• Device Model Number: N/A
• Device Catalogue Number: 00784301526
• Device Lot Number: 60099255
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/01/2021
• Initial Date FDA Received: 10/25/2021
• Supplement Dates Manufacturer Received: 12/30/2021
• Supplement Dates FDA Received: 01/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2003
• 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: Male
• Patient Weight: 77 KG