MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE GLENOID, PEGGED ALPHA, MEDIUM; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Catalog Number 314-02-03

Device Problem Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 02/10/2022

Event Type  Injury  

Event Description

As reported by the equinoxe shoulder study, the 66-year-old female patient had a right tsa on (b)(6) 2012.The patient presented with polyethylene wear on (b)(6) 2022.It is reported that the polyethylene wear was with or without osteolysis - and presented thinning of the rotator cuff and narrowing of the prosthetic joint line signifying thinning of the polyethylene.No action was taken associated with this event and on the visit of (b)(6) 2024, the patient does not yet wish to be re-operated.The outcome of this event is considered continuing.The case report form indicates this event is "possibly" related to device(s) and definitely not related to the procedure.This event report was received through clinical data collection activities and no device return anticipated.

Manufacturer Narrative

(d10) concomitant device(s): 310-01-44 - equinoxe, humeral head short, 44mm (alpha) 300-10-45 - equinoxe replicator plate 4.5mm o/s 300-01-11 - equinoxe, humeral stem primary, press fit 11mm (h3) pending evaluation.

• Brand Name: EQUINOXE GLENOID, PEGGED ALPHA, MEDIUM
• Type of Device: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH; 2320 nw 66th ct.; gainesville FL 32653
• Manufacturer Contact: miguel sosa ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18882261
• MDR Text Key: 337415518
• Report Number: 1038671-2024-00462
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K042021
• 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
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 314-02-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: No
• 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 Age: 66 YR
• Patient Sex: Female
• Patient Weight: 85 KG
• Patient Race: White