MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MODULAR FEMORAL STEM PRESS-FIT PLASMA SPRAYED CEMENTLESS SIZE 12.5; PROSTHESIS, HIP

Model Number N/A

Device Problems Mechanical Jam (2983); Difficult or Delayed Separation (4044)

Patient Problems Host-Tissue Reaction (1297); Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/26/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: catalog number:00784801200, lot number: 61372424, brand name: modular neck; catalog number:00620205222, lot number: 61471539, brand name: acetabular shell; catalog number:00631005032, lot number:61429785, brand name: acetabular liner; catalog number:00801803202, lot number:61484661, brand name: femoral head.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-02877.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.Device not returned for evaluation.

Event Description

It was reported that during a revision surgery, upon attempting to remove the neck from the stem, surgeon noted it was fused.Attempts have been made and additional information on the reported event is unavailable.

Event Description

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

Manufacturer Narrative

Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: patient underwent initial left tha and no complications were noted.8 years post implantation , scans and lab results revealed small joint effusion,an elevated cobalt level of 4.9 and a high chromium level of 3.7 and trunnionosis for which patient was revised.During revision, fusion was noted of the modular trunnion and femoral stem.Trochanter osteotomy was performed without complications and cables were used to repair osteotomy.Reported event was confirmed by review of medical report provided.Device history record was reviewed and no discrepancies were found.Root cause was unable to 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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified signs of being implanted with wear and foreign material.The devices were returned assembled to each other.Medical records were also reviewed and identified fusion noted of the modular trunnion and femoral stem.Review of the device history records identified no deviations or anomalies during manufacturing.No problem was found with the devices as they are designed to achieve stable, long-term fixation.Since the modular neck and stem junction are designed for longevity, the well-connected neck is a desired aspect.This complaint was confirmed based on evaluation of the returned devices.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.H6: proposed component code: mechanical (g04) - stem.

• Brand Name: MODULAR FEMORAL STEM PRESS-FIT PLASMA SPRAYED CEMENTLESS SIZE 12.5
• 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: 8769407
• MDR Text Key: 150366486
• Report Number: 0001822565-2019-02876
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 00771301200
• Device Lot Number: 61365959
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2010
• 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