MAUDE Adverse Event Report: SKELETAL DYNAMICS INC. SKELETAL DYNAMICS; ALIGN RADIAL HEAD SYSTEM

Lot Number AN0913033

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 06/08/2022

Event Type  malfunction  

Event Description

A 59 year old female patient reported pain in her elbow.X-rays revealed the align radial head prostheseis sheared at the neck of the implant.,.

Manufacturer Narrative

The patient experienced compliacations with a radial head prosthesis that was implanted in 2014.The patient regularly played tennis and it appears this may have contributed to this failure.The ifu for this implant states " the patient must be cautioned, preferably in writing, about the use, limitations and possible adverse effects of this device including the possibility of device or treatment failure as a result of stress, excessive activity, weight bearing, or load bearing." this indicates that the implant most likely failed due to strenuous activity over a long period of time.

• Brand Name: SKELETAL DYNAMICS
• Type of Device: ALIGN RADIAL HEAD SYSTEM
• Manufacturer (Section D): SKELETAL DYNAMICS INC.; 7300 n kendall drive; miami FL 33156
• Manufacturer (Section G): SKELETAL DYNAMICS; 7300 n kendall drive; miami FL 33156
• Manufacturer Contact: alejandro ros ; 7300 n kendall drive; miami, FL 33176 ; 3055967585
• MDR Report Key: 14961263
• MDR Text Key: 304183963
• Report Number: 3006742481-2022-00005
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172688
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 07/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: AN0913033
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 59 YR
• Patient Sex: Female
• Patient Weight: 73 KG