MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; HUMERAL STEM PRIMARY, PRESS FIT 11MM

Model Number 300-01-11

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Date 08/01/2019

Event Type  Injury  

Event Description

As reported, approximately 8 months postop the initial right tsa, the (b)(6) y/o male patient presented with intermittent draining wound sinus.Treated conservatively initially, no bug grown.Surgeon decided to perform two stage revision, all implants removed.Evidence of infection present.Devices not returning, sent to rph for analysis.Patient was last known to be in stable condition following the event.

Manufacturer Narrative

Device evaluated by manufacturer? pending evaluation.Concomitant medical device(s): liner, adapter tray.

Event Description

No delay to surgery or patient adverse event.Devices were requested from the hospital, but not returned.No additional information has been provided by the contacts related to this event.

Manufacturer Narrative

As a result of an fda inspection conducted in jan 2020, exactech, fei 1038671, has committed to remediating 3 years of complaints (2017-2020).This mdr is being submitted as part of that remediation.Device(s) not available for evaluation.Design-related issues: as of october 1st, 2021, exactech is aware of 30 complaint reports involving revised shoulder components due to humeral loosening since 2008.Sales data for all humeral stems was used to calculate an approximate complaint occurrence rate of <0.5%.This is considered ¿very low¿ according to the frequency of occurrence ranking scale detailed below.Mfg-related issues: exactech is not aware of any other complaints involving parts from this manufacturing lot of 16 units.The device history record (dhr) for this humeral stem was reviewed, and all parts were accepted with conformance to the device specifications.Therefore, this issue does not appear to be manufacturing-related.Corrective actions are not required because ¿loosening¿of the prosthesis¿ is listed in the product labeling (ifu 700-096-060 rev p), the occurrence rate is ¿very low¿, and the risk is captured in the rmr and racr.The revision reported in case-2021-00004516 was likely the result of an insufficient bond between the humeral stem and the bone, which led to aseptic (non-infected) humeral loosening.However, this cannot be confirmed as the devices were not returned for evaluation and x-rays were not provided.Device(s) used for treatment not diagnosis.Based on review of all available information, there is no evidence to reasonably suggest the reported event is related to any manufacturing issues or design issues.The patient was surgically revised due to humeral loosening.Revisions or surgical interventions are a known complication found in joint replacements.Ifu states: the surgeon shall become thoroughly familiar with the technique of implantation of the prostheses by: (1) appropriate reading of the literature, and (2) training in the operative skills and techniques required for surgery, and (3) reviewing information regarding use of instrumentation.In a review of the labeling, it is a known complication that a patient¿s age, weight, activity level, and/or trauma would cause the surgeon to expect early failure of the system.That there are device specific risks of fracture, migration, loosening, subluxation, or dislocation of the prothesis or any of its components, and 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.Properly functioning implants depend on their appropriate fixation to the bone; fixation can be achieved by cementing the implant onto the prepared bone or by biologic (non-cemented) fixation.Although implants are firmly fixed at the initial surgery, they may become loose over time.In a process called aseptic (non-infected) loosening, the bond of the implant to the bone is destroyed.Aseptic loosening of the humeral stem is an uncommon complication in total shoulder replacements and can be the result of inadequate initial fixation, mechanical loss of fixation over time, stress shielding, or biologic loss of fixation caused by particle-induced osteolysis around the implant.Radiolucency around the humeral component is more frequently noted during follow-up, but does not always correspond to clinical loosening or revision.(1,2) 1) grogan, brian, song, daniel j., jobin, charles m.Cemented humeral shoulder arthroplasty: because it works!, seminars in arthroplasty: june 2018-volume 29, issue 2-p 100-107.Doi: 10.1053/j.Sart.2018.10.009.2) grey, ben mbchb, fcorth(sa), mmed(orth), msc(med)1,a; rodseth, reitze n.Mbchb, fca, mmed, msc, phd2,3; roche, stephen j.Mbchb, fcs(orth)1 humeral stem loosening following reverse shoulder arthroplasty, jbjs reviews: may 2018 - volume 6 - issue 5 - p e5 doi: 10.2106/jbjs.Rvw.17.00129.D6 concomitant devices: 320-38-00, 1960730 , equinoxe reverse 38mm humeral liner +0.320-10-00, 1927596 , equinoxe reverse tray adapter plate tray +0 h11.

Manufacturer Narrative

(h3) investigation currently waiting on a dhr review, another follow up will be sent when completed.Section h11: the following sections have corrected information: (b5) describe event or problem: as reported, the patient had a reverse shoulder replacement previously.It was performing and functioning normally with no issues until recently where it was noted that the humeral stem had become lose and was starting to breach the humerus.Glenoid appeared intact on both x-ray and ct according to surgeon.The surgeon decided to re operate on patient changing the current pressfit size 11 humeral stem.On removing there was no signs of damage to the humeral stem, the liner had minimal wear on the inferior edge but note nothing significant.Revision long stem size 8mm x 175mm was cemented in place, surgeon happy with fixation.Glenoid appeared stabile with good fixation surgeon decided to leave intact.The surgeon used a 10+mm tray adapter, 38mm +2.5mm constrained liner.Patient had good stability.

Event Description

As reported, the patient had a reverse shoulder replacement previously.It was performing and functioning normally with no issues until recently where it was noted that the humeral stem had become lose and was starting to breach the humerus.Glenoid appeared intact on both x-ray and ct according to surgeon.The surgeon decided to re operate on patient changing the current pressfit size 11 humeral stem.On removing there was no signs of damage to the humeral stem, the liner had minimal wear on the inferior edge but note nothing significant.Revision long stem size 8mm x 175mm was cemented in place, surgeon happy with fixation.Glenoid appeared stabile with good fixation surgeon decided to leave intact.The surgeon used a 10+mm tray adapter, 38mm +2.5mm constrained liner.Patient had good stability.

• Brand Name: EQUINOXE
• Type of Device: HUMERAL STEM PRIMARY, PRESS FIT 11MM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 12810458
• MDR Text Key: 284618406
• Report Number: 1038671-2021-00618
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862079312
• UDI-Public: 10885862079312
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K042021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 300-01-11
• Device Catalogue Number: 300-01-11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization