MAUDE Adverse Event Report: EXACTECH, INC. ALT HA S CLR STD SZ 8; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Catalog Number	190-30-08
Medical Device Problem Codes	Use of Device Problem (1670); Migration (4003)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the patient had a left total hip arthroplasty (tha) performed.Postoperatively, in recovery, x-rays showed the femoral stem component exiting through the posterior femoral canal wall.The stem was not in position.The patient was scheduled for a revision tha and femoral stem removal and reimplantation of a monoblock femoral hip stem.The patient was revised and the femoral head and stem were removed and a monoblock stem and femoral head were implanted and confirmed on x-ray intraoperatively.There was no reported breakage of a device and 15-30 minute delay.The patient did not experience any adverse events as a result.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
Pending investigation.Concomitants: 6764138 01-030-01-0862 - alt cup clstr g8 sz 62 a329918 01-030-40-0840 - alt xle lnr ntrl g8 40 a443579 170-40-93 - biolox delta femoral head 40mm od, -3.5mm s206138 180-65-30 - alteon 6.5mm screw, 30mm.
Additional Manufacturer Narrative
Additional information: the initial procedure was performed through an anterior approach.The revision procedure was performed through a posterior lateral approach.Correction: h6.

• Brand Name: ALT HA S CLR STD SZ 8
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
• 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: geoff gannon ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20450507
• Report Number: 1038671-2024-03980
• Device Sequence Number: 12901373
• Product Code: MEH
• UDI-Device Identifier: 10885862321107
• UDI-Public: 10885862321107
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K162732
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 190-30-08
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2024
• Supplement Date Received by Manufacturer: 12/02/2024
• Initial Report FDA Received Date: 10/15/2024
• Supplement Report FDA Received Date: 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male