MAUDE Adverse Event Report: EXACTECH, INC. ALT CUP CLSTR G7 SZ 58; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 01-030-01-0758

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bacterial Infection (1735)

Event Date 03/27/2024

Event Type  Injury  

Event Description

As reported, the 48 year old male patient had an initial left tha on (b)(6) 2022.The patient was revised on an unknown date due to an infected total hip.The implants were removed and a spacer implanted.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.X-rays provided.Product not returning.

Manufacturer Narrative

Section h10: (h3) pending evaluation.(d10) concomitant device(s): 6826277 01-030-40-0736 - alt xle lnr ntrl g7 36.7242930 170-36-03 - biolox delta femoral head 36mm od, +3.5mm.6388935 190-21-08 - alt ha s noclr ext sz 8.

• Brand Name: ALT CUP CLSTR G7 SZ 58
• 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; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: matt collins ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19153988
• MDR Text Key: 340792852
• Report Number: 1038671-2024-00924
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10885862549228
• UDI-Public: 10885862549228
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182502
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/22/2024

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 01-030-01-0758
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2024
• Initial Date FDA Received: 04/22/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/15/2021
• 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
• Treatment: SEE H10
• Patient Age: 48 YR
• Patient Sex: Male