MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number 320-36-00

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 12/20/2022

Event Type  Injury  

Event Description

Study: equinoxe shoulder study; subject: pm069r it was reported via clinical study, that the 61 yo male patient had a deep infection and complained of multiple episodes of sudden slippage and pain in the right shoulder which was relieved by rest.Along with numbness following surgery radiographs of the right shoulder, today shows that the prosthesis is well aligned and located.There was no change from x-rays 3 months prior.On 6-21-22 the patient reported 1 instability episode with erythema around biceps and shoulder.Patient was advised that although there was no clinical signs of infection, redness in the skin can be a subtle sign of infection and for this reason a routine blood test was ordered to determine if there is any systemic evidence of infection.On 7-25-22 shoulder aspiration was ultimately positive for c.Acnes.Therefore a two stage revision procedure was recommended.On 8-5-22 patient underwent or procedure for removal of right total shoulder components, radical debridement of the right gleno-humeral joint and implantation of the cement proximal humeral spacer.Intravenous treatment for c.Acnes at home.On 12-20-22 a right total shoulder revision was performed, and anterior transposition of right ulnar nerve was performed on 12-12-22.Intra-op cultures show no growth.Oral antibiotics.On 3-2-23 (3) months following the revision, patient is doing well.No complaints.Home pt exercises.

Manufacturer Narrative

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 the infection and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.

• Brand Name: EQUINOXE
• Type of Device: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct.; gainesville FL 32563
• Manufacturer Contact: kate jacobson
• MDR Report Key: 16761703
• MDR Text Key: 313526353
• Report Number: 1038671-2023-00717
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086617
• UDI-Public: 10885862086617
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/17/2024

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: Health Professional
• Device Catalogue Number: 320-36-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/24/2023
• Initial Date FDA Received: 04/18/2023
• Supplement Dates Manufacturer Received: 04/08/2024
• Supplement Dates FDA Received: 04/17/2024
• 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?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 77 KG
• Patient Race: White