MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE PROXIMAL FEMUR JTS - SAFETY CLIP; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number UNK_STM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/02/2021

Event Type  Injury  

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 review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.

Event Description

As reported in a letter received by the surgeon: "unfortunately it became clear on the evening of surgery that we had not removed the plastic safety clip at the end of the procedure.Unfortunately there was no representative from stryker in theatre at the time of surgery, and although we had noted and documented during the case that the clip should be removed, it was not.We therefore had to take the patient back to theatre the next day to remove the clip which is made of clear acrylic".

Manufacturer Narrative

Reported event: an event regarding alleged clip not removed from a jts proximal femur was reported.The event was not confirmed.Method & results: product evaluation and results: not performed as the device remained in situ and the clip was not returned.Clinician review: not performed as no medical records were provided.Product history review: review of the product history records indicate the device was manufactured with no reported relevant discrepancies.Complaint history review: there have been no other events for the pin referenced.Conclusions: an event regarding alleged clip not removed from a jts proximal femur was reported.The event was not confirmed.The investigation concluded that the reported event was caused by an user error.A review of both the custom-made patient specific prosthetic replacement instruction for use and the design proposal for pin (b)(4) reported that the retaining clip should removed; failure to due so may lead to future surgical intervention.

Event Description

As reported in a letter received by the surgeon: "unfortunately it became clear on the evening of surgery that we had not removed the plastic safety clip at the end of the procedure.Unfortunately there was no representative from stryker in theatre at the time of surgery, and although we had noted and documented during the case that the clip should be removed, it was not.We therefore had to take the patient back to theatre the next day to remove the clip.Which is made of clear acrylic.".

• Brand Name: PROXIMAL FEMUR JTS - SAFETY CLIP
• 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
• MDR Report Key: 11768442
• MDR Text Key: 248752173
• Report Number: 3004105610-2021-00071
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: K133152
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 06/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: UNK_STM
• Device Lot Number: PIN 22627
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 8 YR