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

Catalog Number ALN-RHI-220

Device Problems Detachment of Device or Device Component (2907); Naturally Worn (2988)

Patient Problems Failure of Implant (1924); Metal Related Pathology (4530)

Event Date 11/08/2023

Event Type  malfunction  

Manufacturer Narrative

The radial head prosthesis was able to function normally in the patient for over four years, prior to a planned surgery in (b)(6).2022 which was performed to address elbow stiffness likely unrelated to the implant.While the area was exposed, the surgeon checked the prosthesis for appropriate placement and evidence of loosening or migration - no issues were found.However, during a follow-up three months later the surgeon observed evidence of metal debris in the area using imaging.The prosthesis was eventually removed in (b)(6).2023.Inspection of the returned hardware indicated that the loose radial head implant had damaged the radial stem implant, which was likely the source of the metal debris.It is likely that some action taken during the (b)(6).2022 surgery was responsible for disrupting the previously stable implant.

Event Description

An align radial head which had been implanted for over five years was removed due to movement of the radial head around the stem.

• Brand Name: SKELETAL DYNAMICS INC.
• Type of Device: ALIGN RADIAL HEAD SYSTEM
• Manufacturer (Section D): SKELETAL DYNAMICS INC.; 7300 n kendall drive; suite 800; miami FL 33156
• Manufacturer (Section G): SKELETAL DYNAMICS INC.; 7300 n kendall drive; suite 800; miami FL 33156
• Manufacturer Contact: baron villalta ; 7300 n kendall drive; suite 800; miami, FL 33156 ; 3055967585
• MDR Report Key: 18297499
• MDR Text Key: 330565042
• Report Number: 3006742481-2023-00018
• 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: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: ALN-RHI-220
• Device Lot Number: AN1706038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2023
• Date Manufacturer Received: 11/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2017
• 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: 26 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White