MAUDE Adverse Event Report: EXACTECH, INC EQUINOXE ANATOMIC REPLICATOR PLATE

Catalog Number 300-10-45

Device Problems Failure To Adhere Or Bond (1031); Metal Shedding Debris (1804); Loosening of Implant Not Related to Bone-Ingrowth (4002)

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

Event Date 01/11/2017

Event Type  Injury  

Manufacturer Narrative

Pending engineering evaluation.

Event Description

Revision due to aseptic loosening/ failure of ingrowth on the stem.Metal debris noted.

Manufacturer Narrative

The complaint products were returned for analysis.The condition was confirmed.Visual evaluation condition/findings (conducted with a 7x or 10x optical) the replicator plate was returned attached to the humeral stem.The markings around the circumference of the replicator plate appear consistent with the disengaged humeral head positioning on the replicator plate taper.The scratches on the inside surface of the retrieved humeral head appear consistent with positioning against the replicator plate taper following the disassociation of the humeral head.The scratches and deformities on the edges of the replicator plate appear consistent with the use of a metal tool to insert the torque screw.X-ray review: the patient had a follow-up every 3 months for a year and a half, following their shoulder arthroplasty.In the 12-month ap x-ray the taper disengagement is visible.It was likely that the humeral head taper was never engaged on the replicator plate due to boney impingement or taper contamination/taper being wet.There appears to be lateral bone up to the humeral head, which may have prevented the humeral head taper from fully engaging.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 other complaint reports involving another part from these manufacturing lots of 15 (humeral stem), 28 (humeral head) and 50 (replicator plate) pieces that have been in the field since 2015, 2013, 2014, respectively.Therefore, this issue does not appear to be manufacturing related.The humeral loosening reported was likely the result of the humeral head taper never being engaged on the replicator plate at the time of initial surgery, due to either boney impingement or taper contamination/taper being wet.In a review of the labeling it is known that device specific risks consist of: fracture, migration, loosening, subluxation, or dislocation of the prothesis or any of its components, any of which may require a second surgical intervention or revision.As part of the preoperative assessment, the surgeon must ensure that no biological, biomechanical, or other factors exist that might adversely affect the surgery and/or postoperative period.Revisions or surgical interventions are a known complication found in joint replacements.All patients should be instructed on the limitations of the prosthesis, the patient should be cautioned to monitor activities and protect the replaced joint from unreasonable stresses and follow the written instructions of the physician with respect to follow-up care and treatment.Possible detachment of the coating(s) on the components, potentially leading to increased debris particles.This device is used for treatment, not diagnosis.No information has been provided.Asked, not answered.

Event Description

It was reported that a patient had a right shoulder revision.Initial surgery date not provided.There has been no additional information provided about the patient or event.This is one of three products involved with the reported event and the associated manufacturer report numbers are 1038671-2017-00042, 1038671-2017-00043 and 1038671-2017-00044.

• Brand Name: EQUINOXE ANATOMIC REPLICATOR PLATE
• Type of Device: REPLICATOR PLATE
• Manufacturer (Section D): EXACTECH, INC; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 6289289
• MDR Text Key: 66445062
• Report Number: 1038671-2017-00044
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/11/2017,05/22/2019

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: 05/06/2019
• Device Catalogue Number: 300-10-45
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2017
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Report to Manufacturer: 01/11/2017
• Initial Date Manufacturer Received: 01/11/2017
• Initial Date FDA Received: 01/31/2017
• Supplement Dates Manufacturer Received: 05/21/2019
• Supplement Dates FDA Received: 05/23/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2014
• 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