MAUDE Adverse Event Report: BRM EXTREMITIES SRL SILKTOE; TOE JOINT POLYMER CONSTRAINED PROSTHESIS

Catalog Number BRDNEWP3030L

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 07/26/2023

Event Type  Injury  

Event Description

It was reported that he stem of a silicone spacer for mtp1 replacement brake off after two months without trauma.

Manufacturer Narrative

The device batch was released on 25/07/2022 and consisted of (b)(4) pieces, which were entirely sold.Dhr review revealed no anomalies, the product complies with the company's requirements.No further reports were received on this batch, while only one other case of device fracture was reported during the entire period of marketing of this device (relating to a different batch).Device fracture is a residual risk reported in ifus.It could be due to different factors; we contacted the distributor asking for more information on event and patient and are waiting for an answer.

• Brand Name: SILKTOE
• Type of Device: TOE JOINT POLYMER CONSTRAINED PROSTHESIS
• Manufacturer (Section D): BRM EXTREMITIES SRL; via lorenzo mascheroni, 29; milano, mi 20145 ; IT 20145
• Manufacturer (Section G): BRM EXTREMITIES S.R.L.; via papa giovanni xxiii; civate, lc 23862 ; IT 23862
• Manufacturer Contact: lisa fazzini ; via papa giovanni xxiii, 9; civate, lc 23862 ; IT 23862
• MDR Report Key: 17659959
• MDR Text Key: 322362807
• Report Number: 3016669046-2023-00001
• Device Sequence Number: 1
• Product Code: KWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191966
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/29/2023

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: BRDNEWP3030L
• Device Lot Number: 0825/22
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/07/2023
• Initial Date FDA Received: 08/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2022
• 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): Hospitalization