MAUDE Adverse Event Report: EXACTECH, INC. EXACTECH; COCR FEM HEAD 36MM +7 OFFSET 12/14

Catalog Number 142-36-07

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 06/18/2019

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.Concomitant medical devices: (cn: 132-36-53 sn: (b)(4)) nv gxl lnr, lipped, 36mm id, group 3 cups; (cn: 120-65-20 sn: (b)(4)) bone screw 6.5mm dia x 20mm long; (cn: 120-65-25 sn: (b)(4)) bone screw 6.5mm dia x 25mm long; (cn: 160-10-13 sn: (b)(4)) pf stem taper plasma h/a sz 13; (cn: 180-01-58 sn: (b)(4)) nv crown cup clstr hole 58mm group 3 ; (cn: 120-65-35 sn: (b)(4)) bone screw 6.5mm dia x 35mm long.

Event Description

Patient had pain in hip.The surgeon replaced the exactech femoral head with another of the exact size as the original.The surgeon changed out the cup and shell in more anteversion position using another vendor.

Manufacturer Narrative

Section h10: (h3) the clinical evaluation noted that a 79 y/o patient complained of pain in the hip and was scheduled for revision.The surgeon replaced the exactech femoral head with another of the exact size as the original and changed out the cup and shell in more anteversion position using another vendor.Device was used for treatment, not diagnosis.There is no indication that there is a device related problem, there is no allegation against the device.The most likely cause of the reported event is related to the underlying patient conditions.No information provided in the following section(s): a3, a4, a5, b6 and b7.The following section(s) have additional info: d4 (udi number) g4, g7, h1, h2, h3, and h7.

• Brand Name: EXACTECH
• Type of Device: COCR FEM HEAD 36MM +7 OFFSET 12/14
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 8755137
• MDR Text Key: 149850575
• Report Number: 1038671-2019-00348
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: K041906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/19/2015
• Device Catalogue Number: 142-36-07
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR