MAUDE Adverse Event Report: EXACTECH, INC. HIP - IMPLANTS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number CROWN CUP

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Failure of Implant (1924)

Event Date 10/29/2023

Event Type  Injury  

Event Description

As reported, approximately four months post initial tha, the 80 y/o female had a revision due to our cup moving from its original position and bone loss, the cup was revised to a cup cage from competitor's device.The exactech cup, liner, bone screw, and femoral head were removed from the patient.The original exactech femoral stem remained in the patient and an exactech biolox options 36mm +0mm head was implanted on our femoral stem.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Sales rep was unable to obtain x-rays or images.The devices are not available for evaluation due to hospital policy.

Manufacturer Narrative

Section d10: concomitant products.Cocr fem head 32mm +0 offset 12/14 (cat# 142-32-00 / serial# (b)(6)).Novation xle liner (cat# 142-32-61 / serial# (b)(6)).- alteon 6.5mm screw, 30mm (cat# 180-65-30 / serial# (b)(6)).Additional information, including the product investigation, will be submitted within 30 days of receipt.

• Brand Name: HIP - IMPLANTS
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson
• MDR Report Key: 18179637
• MDR Text Key: 328615172
• Report Number: 1038671-2023-02824
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 11/21/2023

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 Model Number: CROWN CUP
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/30/2023
• Initial Date FDA Received: 11/21/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female