MAUDE Adverse Event Report: EXACTECH, INC. ALT HA S NOCLR EXT SZ 7; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER

Catalog Number 190-21-07

Device Problem Unintended Movement (3026)

Patient Problem Failure of Implant (1924)

Event Date 08/29/2023

Event Type  Injury  

Manufacturer Narrative

Pending investigation.D10: 170-32-07 - biolox delta femoral head 32mm od, +7mm 6218314.01-030-40-0332 - alt xle lnr ntrl g3 32 a150675.01-030-01-0348 - alt cup clstr g3 sz 48 a381411.180-65-30 - alteon 6.5mm screw, 30mm s399575.

Event Description

As reported, the patient had an initial left tha on (b)(6) 2023 and has since subsided.The patient was revised on (b)(6) 2023 and implanted with competitor's devices.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.

• Brand Name: ALT HA S NOCLR EXT SZ 7
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17774912
• MDR Text Key: 323748192
• Report Number: 1038671-2023-02313
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162732
• 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: 09/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 190-21-07
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/26/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female