MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM; HIP PROSTHESIS

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Pain (1994); Limited Mobility Of The Implanted Joint (2671)

Event Date 03/01/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to unknown product location.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.(b)(4).Medical devices: item # 00999301745, femoral body, lot # 62411391.Multiple reports have been submitted for this event.Please see associated reports: 0001822565-2018-02400, 0001822565-2018-02401.

Event Description

It was reported that a patient underwent a revision surgery approximately 4 years post implantation due to implant fracture.The patient stood up from couch, and felt severe pain.Due to the pain and implant fracture, the patient suffered from limited mobility.Attempts have been made, and no further information has been provided.

Manufacturer Narrative

Reported event was confirmed by review of radiographs.The x-ray review determined the classification for the patient's femur falls in paprosky classification type 2 defect.The x-ray review also confirmed the proximal support and the size of proximal body were inadequate.Device history record (dhr) was reviewed and no discrepancies were found.Likely root cause of the stem fracture was determined to be lack of proximal support.A summary of the investigation has been sent to the complainant.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
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7492676
• MDR Text Key: 107561740
• Report Number: 0001822565-2018-02401
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• PMA/PMN Number: PK992667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/14/2018

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: Physician
• Device Expiration Date: 04/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 00998201513
• Device Lot Number: 62356798
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/09/2018
• Initial Date FDA Received: 05/07/2018
• Supplement Dates Manufacturer Received: 06/14/2018
• Supplement Dates FDA Received: 06/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 37 YR
• Patient Weight: 85