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

Model Number SMALL CAGED GLENOID

Device Problem Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 03/27/2024

Event Type  Injury  

Event Description

As reported, the 72 y/o female patient had complained of pain for approximately 4 years (implants were put in 7-8 years ago).However, due to covid it had not been possible to x-ray/ct the patient so the surgeon is not fully clear what route of deterioration had been taking place.Patient first stage revision of a caged glenoid anatomic.All implants removed and replaced with a spacer.The patient's rotator cuff failed.Patient lost function.During the surgery the 3 x peripheral pegs and attached polyethylene were retrieved.The caged glenoid appeared to have significantly 'eroded' with possible erosion after being lodged under the humeral head.The medial calcar had also completely disappeared due to possible stress shielding.There was significant metalosis observed leading to the belief that this could have been the cage.There was no evidence of the cage being anywhere else (as per x-rays and ct's).The surgeon explored all reasonable options to find it but there was no sight of it.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Sales rep was unable to obtain photos and x-rays.The devices are not available for evaluation due to it is not hospital policy to release implants.Request has been made none the less.If approved, they will be collected and sent to gv.

Manufacturer Narrative

Section d10: concomitant products 41mm head.4.5mm replicator plate.11mm humeral stem.Additional information, including the product investigation, will be submitted within 30 days of receipt.

• Brand Name: SHOULDER - IMPLANT
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: matt collins
• MDR Report Key: 19154225
• MDR Text Key: 340736496
• Report Number: 1038671-2024-00927
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SMALL CAGED GLENOID
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2024
• 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 Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female