MAUDE Adverse Event Report: EXACTECH, INC. ACUMATCH 15 DEGREE LINER 32MM SZ G; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 132-32-07

Device Problem Insufficient Information (3190)

Patient Problem Failure of Implant (1924)

Event Date 03/21/2005

Event Type  Injury  

Manufacturer Narrative

(d10) concomitant device(s): 630998 - 114-31-03 - acumatch p-ser porous hi offset w/o col, sz 3 665219 - 120-01-54 - acumatch cluster cup porous coated 54mm 333932 - 120-65-45 - bone screw 6.5mm dia x 45mm long 560850 - c-32s - ceramic head 32mm -5mm neck.

Event Description

It was reported that a patient who had an initial hip implanted on (b)(6) 2005, is scheduled for a revision procedure on (b)(6) 2024, approximately 19 years 1 month post the initial procedure.The revision is with an old acumatch p-series stem and the early version of the acumatch liner.The fem head is ceramic.The surgeon requested if there is a constrained liner that fits the cup implanted.Follow up indicated that it¿s definitely a 1113 taper and we only have cobalt for those.We do have a face changing for a 36 head that will be a size g and will fit in this cup.The acumatch is a 15 degree and the constrained are 0 degrees.Kit 180 novation constrained liner kits, kit 181 are the instruments.No further information.

• Brand Name: ACUMATCH 15 DEGREE LINER 32MM SZ G
• 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 32653
• Manufacturer Contact: matt collins ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19112045
• MDR Text Key: 340222710
• Report Number: 1038671-2024-00848
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10885862023209
• UDI-Public: 10885862023209
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993082
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/15/2024

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: 132-32-07
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/15/2024
• 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 Sex: Male