MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE METS PROXIMAL HUMERUS BAYLEY/WALKER; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number UNK_STM

Device Problem Component Missing (2306)

Patient Problems Injury (2348); Cancer (3262)

Event Date 05/03/2019

Event Type  Injury  

Manufacturer Narrative

The reported device is similar to a device approved for compassionate use in the united states.An event regarding alleged missing component involving mets proximal humerus (bayley/walker) components was reported.The event was confirmed.Method and results product evaluation and results: not applicable as complaint relates to missing component dispatch.No specific device batch/lot has been reported to have failed.Clinician review: no medical records were received for review with a clinical consultant, issue relates to missing component dispatch.Product history review: not applicable as complaint relates to missing component dispatch.No specific device batch/lot has been reported to have failed.Complaint history review: based on the device identification the complaint databases were reviewed from 06may2016 to present for similar reported events regarding missing component in a kit for mets proximal humerus (bayley/walker).There have been no other events.The investigation concluded that the alleged missing component was communicated to the customer but the kit was dispatched prior to the required customer acknowledgement.An nc was issued (b)(6) 2019 to further investigate the reported issue.

Event Description

It has been reported that "we routinely check and arrange all implants.We find that the left sided proximal humerus components (bayley walker linkage type) were not available.His surgery was to be on the left side, i had to stop and get the patient out of anesthesia".Update: "patient taken under anesthesia and brought out without surgery due to absence of the required components.Delay: 4 weeks delay as we had to wait for components to arrive and meanwhile had to restart chemo.Patient had unnecessary expense of surgery, travel to and stay in (b)(6).".

• Brand Name: METS PROXIMAL HUMERUS BAYLEY/WALKER
• 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; GB WD6 3SJ
• Manufacturer (Section G): STANMORE IMPLANTS WORLDWIDE; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3 SJ; GB WD6 3SJ
• Manufacturer Contact: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; GB WD6 3SJ ; 2082386500
• MDR Report Key: 9178724
• MDR Text Key: 173226535
• Report Number: 3004105610-2019-00113
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_STM
• Device Lot Number: CRC PH 303636
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2019
• 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): Hospitalization; Required Intervention
• Patient Age: 20 YR