MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; HUMERAL LONG STEM 8MM 175MM

Model Number 306-01-08

Device Problems Loose or Intermittent Connection (1371); Component Missing (2306); Positioning Problem (3009); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)

Event Date 08/16/2019

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.Concomitant device(s): reverse adapter plate +0 (cat# 320-10-00 / sn# (b)(4)), torque defining screw kit (cat# 320-20-00 / sn# (b)(4)), 42mm reverse constrained humeral liner +0 (cat# 320-42-10 / sn# (b)(4)).

Event Description

This female patient had a total shoulder arthroplasty on her right shoulder.She had a subsequent revision surgery which took place on (b)(6) 2014 and was performed at (b)(6) hospital.It seems that the surgeon revised the humeral components in place and used a humeral long stem (8x175) for this patient.The cemented long revision stem, had become extremely loose and spun 180 degrees within the humeral canal, resulting in the need for a second revision surgery.When the surgeon dissected down to the implants and removed the stem it had no cement on it.A revision was done to place a fluted cemented fracture stem in its place.Operation was a success, patient left the or in stable condition and surgeon expects patient to do well.

Manufacturer Narrative

Section h10: (d6) if implanted, give date: (b)(6) 2014 (h3) the revision reported was likely the result of an insufficient bond between the implant, host bone, and allograft, which could have limited the amount of cement between the humeral stem and humeral canal and 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.(h6) evaluation codes: 1924, 4002.Section h11: the following sections have corrected information: (b5) describe event or problem: as reported, this female patient had a total shoulder arthroplasty on her right shoulder.We are unsure of when this was performed and by whom.She had a subsequent revision surgery which took place on (b)(6) 2014 and was performed.It seems that that the humeral components were revised in place and used a humeral long stem (8x175) for this patient.The cemented long revision stem, had become extremely loose and spun 180o within the humeral canal, resulting in the need for a second revision surgery.When the surgeon dissected down to the implants and removed the stem it had no cement on it, and surgeon complained the round smooth cemented design was the issue.A revision was done to place a fluted cemented fracture stem in its place.Operation was a success, patient left the or in stable condition and surgeon expects patient to do well.Explants were kept by hospital as they do not allow us to take them.*no information provided in the following section(s): a4, a5, b6, b7, g8, h7, h9.

Event Description

As reported, this female patient had a total shoulder arthroplasty on her right shoulder.We are unsure of when this was performed and by whom.She had a subsequent revision surgery which took place on (b)(6) 2014 and was performed.It seems that that the humeral components were revised in place and used a humeral long stem (8x175) for this patient.The cemented long revision stem, had become extremely loose and spun 180o within the humeral canal, resulting in the need for a second revision surgery.When the surgeon dissected down to the implants and removed the stem it had no cement on it, and surgeon complained the round smooth cemented design was the issue.A revision was done to place a fluted cemented fracture stem in its place.Operation was a success, patient left the or in stable condition and surgeon expects patient to do well.Explants were kept by hospital as they do not allow us to take them.

• Brand Name: EQUINOXE
• Type of Device: HUMERAL LONG STEM 8MM 175MM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9179100
• MDR Text Key: 169825090
• Report Number: 1038671-2019-00505
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862083784
• UDI-Public: 10885862083784
• Combination Product (y/n): N
• PMA/PMN Number: K042021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/17/2013
• Device Model Number: 306-01-08
• Device Catalogue Number: 306-01-08
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR