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

Model Number 190-31-08

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Date 03/02/2023

Event Type  Injury  

Event Description

As reported, the male patient had an initial left tha on (b)(6) 2019.The patient was brought back for left hip pain and the x-rays showed a loose stem.The femur was dislocated and the femoral head removed.The stem was checked and found to be loose and subsided.It had fixation distally, but not proximally.Osteotomes and a high speed burr were used to help get the stem out.The stem is pretty banged up.The stem was removed with the help of a slap hammer.Attention turned to the cup.The liner was removed with the help of a screw.A new g2 lipped xle liner was implanted.A 19 x 245 monobloc stem was implanted with a 36 +0 head.The event is not related to the breakage of a device and did not lead to surgical delay/prolongation.The patient was last known to be in stable condition following the event.No additional patient information/medical history reported.

Manufacturer Narrative

Pending investigation.Concomitant medical products : 5430262 140-36-52 - nv ehxl ntrl lnr g2 36mm, 5181913 170-36-07 - biolox delta femoral head 36mm od, +7mm, 5219101 186-01-54 - integrip cc, cluster 54mm, g2.

• Brand Name: ALT HA S CLR EXT SZ 8
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS
• 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: 16651882
• MDR Text Key: 312406004
• Report Number: 1038671-2023-00554
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 10885862320971
• UDI-Public: 10885862320971
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/17/2022
• Device Model Number: 190-31-08
• Device Catalogue Number: 190-31-08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2017
• 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 Sex: Male