MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE LTD CUSTOM PROXIMAL FEMUR JTS REPLACEMENT IMPLANT; LIMB SALVAGE SYSTEM

Model Number BME19099

Device Problems Component or Accessory Incompatibility (2897); Appropriate Term/Code Not Available (3191)

Patient Problems No Known Impact Or Consequence To Patient (2692); Cancer (3262)

Event Date 01/20/2015

Event Type  malfunction  

Event Description

A surgeon reported that during a procedure to implant a jts proximal femur replacement implant it was noted that the custom acetabular reamer dimension was missing from the op drawing.Additionally the reamer supplied did not work resulting in the surgeon having to use reamers from hosp stock.

Manufacturer Narrative

A review of the mfg records confirms that the device was manufactured to spec and that no non-conformities were identified.The device is not available for eval.The investigation is ongoing, a supplemental report will be provided upon completion.Please note that the kts proximal femur replacement implant is similar to mets modular proximal femur (k121056).

Manufacturer Narrative

The patient underwent successful revision of the custom proximal femur jts.As documented in the original investigation, the reamer dimension was not on the drawing as it was clearly visible on the side of the device and the dimension was as specified by the surgeon (not specified by stanmore implants).The reamer was made to the surgeon's specified dimensions by subcontracted manufacturer.The subcontract manufacturer supplied certificates of conformity and inspection certificates to stanmore implants.The surgeon approved the design proposal, which did not include the reamer dimensions and the reamer was also approved as a separate picture.The surgeon's complaint that the reamer dimensions were missing from the drawing is unfounded as he had already approved the design proposal drawing which did not include the reamer or its dimension.The surgeon's complaint that the reamer did not work could not be confirmed as the device was not returned for investigation.The surgeon has stated that he does not want this style of reamer again which indicates that this could be due to the surgeon's preference not a fault with the reamer, (note that the surgeon had seen and approved the reamer before it was dispatched to him).No further investigation is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.The complaint is being closed and tracked and trended.Corrected data: common device name/product code was corrected from "prosthesis, knee, femerotibial, cots/kro" to "limb salvage system/jdi".

Event Description

The surgeon reported that during a procedure to replace a jts proximal femur replacement implant it was noted that the custom acetabular reamer dimension was missing from the op drawing.Additionally the reamer supplied did not work, resulting in the surgeon having to use a reamer from hospital stock.This is a supplemental report to 3004105610-2015-00013 ((b)(4)).

• Brand Name: CUSTOM PROXIMAL FEMUR JTS REPLACEMENT IMPLANT
• Type of Device: LIMB SALVAGE SYSTEM
• Manufacturer (Section D): STANMORE IMPLANTS WORLDWIDE LTD; 210 centennial avenue; centennial park; elstree, WD6 3 SJ; UK WD6 3SJ
• Manufacturer (Section G): STANMORE IMPLANTS WORLDWIDE LTD; 210 centennial avenue; centennial park; elstree, 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: 4534801
• MDR Text Key: 5518792
• Report Number: 3004105610-2015-00013
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K121056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,foreign,health professi
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/18/2015
• Device Model Number: BME19099
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/20/2015
• Initial Date FDA Received: 02/17/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 7 YR