MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE UNKNOWN JTS EXTENSION MECHANISM; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number UNK_STM

Device Problem Failure to Advance (2524)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/12/2022

Event Type  malfunction  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

Distributor requested a booster jts drive unit.When details were requested, the following was reported: "at the extension.The device did not extend.I understand there is a booster device that can be sent (that is a stronger magnet) is that correct?".

Manufacturer Narrative

Upon further investigation the event of the patient¿s jts implant seizing has previously been reported under pi (b)(4) mdr ref 3004105610-2021-00162.This pi (b)(4) mdr ref 3004105610-2022-00020 is a duplicate.Since the same failure for the same device has been reported twice pi (b)(4) mdr ref 3004105610-2022-00020 will be cancelled as a duplicate.

Event Description

Distributor requested a booster jts drive unit.When details were requested, the following was reported: "at the extension, the device did not extend.I understand there is a booster device that can be sent ( that is a stronger magnet) is that correct?".

• Brand Name: UNKNOWN JTS EXTENSION MECHANISM
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STANMORE IMPLANTS WORLDWIDE; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3 SJ; UK WD6 3SJ
• Manufacturer (Section G): STANMORE IMPLANTS WORLDWIDE; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3 SJ; UK WD6 3SJ
• Manufacturer Contact: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 13558870
• MDR Text Key: 285817047
• Report Number: 3004105610-2022-00020
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: IS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_STM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other