MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE DISTAL FEMORAL REPLACEMENT - PLATEAU PLATE; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number UNK_STM

Device Problem Device-Device Incompatibility (2919)

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

Event Date 04/22/2021

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 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.Device not returned.

Event Description

The sales rep reported "the custom design came with x2 tibial plateau plates (standard, 5 mm & 10 mm) as an intra-operative surgery option.This plateau plate did not fit/mate with the anti-rotation lugs on the left custom tibial component.The surgeon observed that the spacing distance between the lugs & the holes in the std plateau plate were not compatible.After deliberation, the surgeon requested that a small tibial plateau plate be opened, (the account have their own small tibial plateau plates on consignment).It was subsequently opened, and fit/mated well with custom tibial component.The surgeon suggested that in his opinion, this custom was sent out with incompatible standard tibial plateau plates, when the sizing should have been small.

Event Description

The sales rep reported "the custom design came with x2 tibial plateau plates (standard, 5mm & 10mm) as an intra-operative surgery option.This plateau plate did not fit/mate with the anti-rotation lugs on the left custom tibial component.The surgeon observed that the spacing distance between the lugs & the holes in the std plateau plate were not compatible.After deliberation, the surgeon requested that a small tibial plateau plate be opened, (the account have their own small tibial plateau plates on consignment).It was subsequently opened, and fit/mated well with custom tibial component.The surgeon suggested that in his opinion, this custom was sent out with incompatible standard tibial plateau plates, when the sizing should have been small.

Manufacturer Narrative

Reported event: an event regarding size/fit issue involving a patient specific, distal femoral replacement, tibial component was reported.The event was confirmed by senior designer review.Method & results: device evaluation and results: not performed as product was not returned.Clinician review: no medical records were received for review with a clinical consultant.Device history review: review of the product history records indicate the device was manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for the lot referenced product surveillance will continue to monitor for trends.Conclusion: review of the proposal shows, the anti rotation pegs of the tibial component under pin 22362 were not compatible with the supplied plateau plate.The plateau plate was standard to match the bone profile, the lugs of the tibial component were small, thus the standard plateau plate provided could not fit.The investigation concluded that the size/fit issue was caused by the positioning of the anti-rotation lugs (a/r lugs) of the tibial component which should have been modified to fit the corresponding holes on the plates, to allow proper assembly.An nc was raised to address the size/fit issue of pin 22362.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: DISTAL FEMORAL REPLACEMENT - PLATEAU PLATE
• 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: 11818178
• MDR Text Key: 250418995
• Report Number: 3004105610-2021-00075
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: K140898
• 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: 08/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: UNK_STM
• Device Lot Number: PIN 22632
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 55 YR