MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM BEADED FULLCOAT 12/14 160 MM LENGTH; PROSTHESIS, HIP

Model Number N/A

Device Problems Material Erosion (1214); Migration (4003)

Patient Problems Necrosis (1971); Pain (1994); Joint Dislocation (2374); Osteolysis (2377); Ambulation Difficulties (2544); Metal Related Pathology (4530); Muscle/Tendon Damage (4532); Unequal Limb Length (4534)

Event Date 12/28/2023

Event Type  Injury  

Event Description

It was reported that the patient underwent a revision procedure approximately 5 years post implantation due to the development of pain, limb length discrepancy, instability with recurrent dislocations, and metallosis.During the procedure large gray-black synovial effusion, extensive osteolysis and necrotic lesion of r hip soft tissue with complete loss of hip abductor attachments on proximal femur noted.There was extensive debridement of r hip pseudotumor.Gross black debris around the femoral trunnion, the patient underwent revision, the head and liner components were exchanged without complications.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0002648920 - 2024 - 00019, 0001822565 - 2024 - 00207.D10: cat# 00625006535 lot# 64001146 bone scr 6.5x35 self-tap cat# 00875705401 lot# 64009913 54mm o.D.Size jj porous uncemented with cluster holes shell use with jj liners.The customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

No further information at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Proposed component code: mechanical (g04)- stem.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.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: an initial right tha was performed.The patient presented with pain, dislocations, instability, leg length discrepancy, and metallosis.A revision was performed with osteolysis and pseudotumor noted.Black debris was noted on the trunnion.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: right total hip arthroplasty without hardware failure or loosening.Patient body habitus does limit evaluation significantly.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 BEADED FULLCOAT 12/14 160 MM LENGTH
• Type of Device: PROSTHESIS, HIP
• 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: 18562158
• MDR Text Key: 333445612
• Report Number: 0001822565-2024-00206
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00889024136434
• UDI-Public: (01)00889024136434(17)260930(10)63429634
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K973714
• 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: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2024
• 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: 00784301126
• Device Lot Number: 63429634
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2016
• 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: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 95 KG