MAUDE Adverse Event Report: EXACTECH, INC. EXACTECH FEMORAL HEAD, COBALT CHROMIUM, 32MM OD

Catalog Number 100-32-95

Device Problems Deformation Due to Compressive Stress (2889); Naturally Worn (2988); Migration (4003)

Patient Problems Pain (1994); Joint Disorder (2373); Osteolysis (2377)

Event Date 05/27/2018

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Index surgery: 2005.Revision due to poly wear, osteolysis, and pain.

Manufacturer Narrative

The complaint products were received for analysis.The reported malfunction/product condition of polyethylene wear was confirmed.Visual evaluation condition/findings (conducted with a 7x or 10x optical) - acetabular liner: the deformation consistent with edge-directed loading in an area of unsupported polyethylene.The scratching appears consistent with using an osteotome to remove the femoral head from the liner during the revision surgery.The scratches on the backside of the liner appear consistent with the use of a sharp tool to remove the liner from the acetabular shell.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 frequency of occurrence ranking scale is very low; therefore, this does not appear to be design-related.The company is not aware of receiving any complaint reports involving another part from this manufacturing.Company complaint data from 2014 through 2018 involving the reported failure for this family of devices was reviewed.The investigations for those incidences have not identified any evidence that a manufacturing issue caused or contributed to this reported issue.There were no user-related issues reported that appear to have contributed to the reported event.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.The polyethylene wear may have led to osteolysis and pain, but this cannot be confirmed by the device evaluation.The revision reported in this event 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.The polyethylene wear may have led to osteolysis and pain, but this cannot be confirmed by the device evaluation.In a review of the labeling it is a known that a device specific risk is osteolysis and pain is a known specific risk of joint replacement surgery.A malpositioned component may increase the probability for impingement, disassociation, dislocation, wear and revision surgery.It is a known risk of joint replacement devices that there may be subsequent revisions or surgical interventions.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of prosthesis wear is most likely associated with edge-directed loading in an area of unsupported polyethylene, which led to vertical migration of the femoral head.The polyethylene wear may have led to osteolysis and pain these conditions could be further aggravated by the patient's underlying conditions to include previous hip joint surgeries.This device is used for treatment, not diagnosis.Corrected data: b5: describe event or problem (index surgery 2005 is incorrect) and d4:.Model number.

Event Description

Patient was fine when leaving the or.No additional information was provided.This is one of three products involved with the reported event and the associated manufacturer report numbers 1038671-2018-00480 and 1038671-2018-00481.

• Brand Name: EXACTECH FEMORAL HEAD, COBALT CHROMIUM, 32MM OD
• Type of Device: EXACTECH FEMORAL HEAD, COBALT CHROMIUM, 32MM OD
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• MDR Report Key: 7558047
• MDR Text Key: 109700832
• Report Number: 1038671-2018-00479
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: K862234
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/13/2019

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: 05/14/2017
• Device Catalogue Number: 100-32-95
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/27/2018
• Initial Date FDA Received: 05/31/2018
• Supplement Dates Manufacturer Received: 03/12/2019
• Supplement Dates FDA Received: 03/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 66