MAUDE Adverse Event Report: EXACTECH, INC. ACUMATCH CLUSTER CUP POROUS COATED 50MM

Catalog Number 120-01-50

Device Problems Deformation Due to Compressive Stress (2889); Naturally Worn (2988)

Patient Problems Joint Disorder (2373); No Code Available (3191)

Event Date 02/26/2018

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Index surgery: 2012.Revision of acumatch hip components due to poly wear.

Event Description

It was reported from brazil.The surgeon was unable to remove the stem and it remained in the patient.No additional information was provided.This is one of four products involved with the reported event and the associated manufacturer report numbers are 1038671-2018-00288, 1038671-2018-00289, 1038671-2018-00290 and 1038671-2018-000291.

Manufacturer Narrative

Section h3: the complaint products were received for analysis.The reported condition of prosthesis wear was confirmed.Visual evaluation condition/findings (conducted with a 7x or 10x optical): the returned acetabular shell- appears to have bone and bone cement adhered to the porous surface.The bone and bone cement adhered to the porous surface of the shell appears consistent with successful on-growth and fixation between the shell and the host bone.The returned acetabular liner- the deformation appears consistent with edge-directed loading in an area of unsupported polyethylene.Scratches appear consistent with using an osteotome to remove the femoral head from the liner during the revision surgery.The discoloration appears consistent with retained biological remnants from being implanted.The cold flow markings are impressions of the screw holes in the acetabular shell on the back side of the liner.The sharp delineation of these markings indicates that there was no significant relative movement between the liner and the shell during implantation.The alignment of the femoral head appears consistent with the center of rotation migrating vertically due to progressive wear in the direction of the applied load.The returned acetabular screw- the displaced material on the head of the screw appears consistent with deformation due to contact between the sharp edge of the screw head and the inner surface of the screw hole.This can occur when the screw is inserted at an angle and contacts the inner surface of the screw hole as it advances.The frequency of occurrence ranking scale is very low; therefore, this does not appear to be design-related.The company has not received any other complaint reports involving parts from any of the manufacturing lots.A review of the device history record showed that the named devices were accepted with conformance to the device requirements.Therefore, this does not appear to be manufacturing-related.There were no user-related issues reported that would contribute to the reported polyethylene wear.The revision reported was likely the result of polyethylene wear associated with edge-directed loading in an area of unsupported polyethylene, which led to vertical migration of the femoral head.Section h6: in review of labeling it is a noted device specific risk of fracture, migration, loosening, subluxation, or dislocation of the prosthesis or any of its components, any of which may require a second surgical intervention or revision.Excessive wear of the implant components secondary to impingement of components or damage of articular surfaces.It is a known contraindication for use in patients whose weight, age, or activity level would cause the surgeon to expect early failure of the system.It is part of the preoperative assessment by the surgeon to ensure that no biological, biomechanical, or other factors exist that might adversely affect the surgery and/or postoperative period.Bone quality must be considered to ensure that the prosthesis does not subside or migrate within the femoral canal or acetabulum; fracture of host bone should also be considered.This device is used for treatment, not diagnosis.

• Brand Name: ACUMATCH CLUSTER CUP POROUS COATED 50MM
• Type of Device: CUP
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• MDR Report Key: 7423043
• MDR Text Key: 105211965
• Report Number: 1038671-2018-00291
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: K993082
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/27/2019

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: Physician
• Device Expiration Date: 07/13/2016
• Device Catalogue Number: 120-01-50
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/02/2018
• Initial Date FDA Received: 04/11/2018
• Supplement Dates Manufacturer Received: 03/26/2019
• Supplement Dates FDA Received: 03/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Weight: 61