MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MODULAR FEMORAL STEM PRESS-FIT; PROTHESIS, HIP

Model Number N/A

Device Problems Fracture (1260); Detachment of Device or Device Component (2907)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 05/22/2023

Event Type  Injury  

Event Description

It was reported that approximately 13 years post implantation of a left total hip arthroplasty the patient required a left hip revision.The patient had reportedly been seated in a chair and went to transition from a sitting to a standing position and experienced an acute onset of severe left hip pain.Subsequently, the patient was revised due to a mechanical failure of the left hip prosthetic.During the revision, it was noted that the broken trunnion, the femoral head, and part of the neck were visualized in the acetabulum.The revision was completed without complications.No additional information was available.

Manufacturer Narrative

(b)(4).D10: highly cross-linked polyethylene with 10 degree elevated rim.Zimmer triology acetabular cup with a 62mm outer diameter.Cat# 00801803202, lot# 61558172, zimmer versys femoral head 32mm diameter with 0 neck length.Cat# 00784803400, lot# 61589645, zimmer modular neck size j.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.Multiple mdr reports were filed for this event, please see associated report: 0001822565-2023-01436.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: component code: mechanical (g04)-stem.No product was returned; however, pictures were provided.A visual examination of the provided pictures identified that the stem was fractured near the junction of the neck and head, and the bottom of the neck appeared to be fractured as well.The head remained assembled to the neck.All products were covered in bio-debris.No further evaluation could be made from the provided pictures.Medical records were also provided and reviewed by a health care professional.A review of the available records identified the following: an initial left total hip arthroplasty was performed.Approximately 13 years post implantation, the patient experienced sudden pain when standing up from sitting.It was identified that the stem and neck were broken, and the neck and head were located in the acetabulum during the revision.The neck, stem, and head were explanted with no complications noted.Radiographs were also provided and reviewed by a health care professional.A review of the available records identified the following: left total hip arthroplasty with a fractured junction of the femoral neck and femoral stem.A review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.The reported head, neck, and stem were reviewed for compatibility with no issues noted.However, as the liner and shell are unknown, it could not be determined if the entire construct is compatible.This complaint was confirmed based on the provided pictures and medical records.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 is available at the time of this report.

• Brand Name: MODULAR FEMORAL STEM PRESS-FIT
• Type of Device: PROTHESIS, 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: 17144092
• MDR Text Key: 317322095
• Report Number: 0001822565-2023-01435
• Device Sequence Number: 1
• Product Code: KWA
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/01/2023

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: 07/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 65771301300
• Device Lot Number: 00116220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/23/2023
• Initial Date FDA Received: 06/16/2023
• Supplement Dates Manufacturer Received: 07/26/2023
• Supplement Dates FDA Received: 08/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2010
• 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
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 116 KG