MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE DISTAL FEMUR; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number UNK_STM

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Inflammation (1932)

Event Date 05/20/2020

Event Type  Injury  

Manufacturer Narrative

An investigation is being performed in an attempt to identify the cause of the event.Should additional information become available it will be reported in a supplemental report.Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.Catalog numbers and lot codes of other devices listed in this report: smbpr02, (b22017), smiles knee bumper pad standard.Smbsh02, (b22140), smiles knee bushes standard.Smcic01, (b22031), smiles knee circlip mk2.Tibial plateau plate, unknown lot.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

Event Description

"this is a new case ¿ revision of pin 21508 for sepsis.Initial device removed last week and spacer put in place.Op date scheduled (b)(6).The surgeon filed and signed our previous implant prescription form.The revision surgery with insertion of a spacer was last week.The first surgery was (b)(6) 2018 ¿ pin 21508 as mentioned.

Event Description

"this is a new case ¿ revision of pin 21508 for sepsis.Initial device removed last week and spacer put in place.Op date scheduled july 28.The surgeon filed and signed our previous implant prescription form.The revision surgery with insertion of a spacer was last week.The first surgery was (b)(6) 2018 ¿ pin 21508 as mentioned".Update - the reason for revision is infection, not sepsis.

Manufacturer Narrative

Additional manufacturer narrative: reported event: an event regarding infection involving a patient specific, distal femur was reported.The event was confirmed by x-ray review.Method & results: device evaluation and results: not performed as product was not returned.Clinician review: a review of the provided x-rays by a clinical consultant indicated: the implant in situ was for a distal femoral replacement which was inserted on (b)(6) 2018.The surgeon reported infection of the implant.The image provided showed that the distal femoral implant has been removed and the temporary spacer and put are in situ.The remaining cortical bone of the femur near the resection showed bone resorption and blurry which suggests that the bone has had inflammatory process due to infection.Therefore, the radiographic review can confirm the clinical report and the reason for revision.Device history review: review of the product history records indicate 1 device was manufactured and accepted into final stock on 04sep2018 with no reported discrepancies.Complaint history review: there have been 3 other events.Sterile lot: uk34s12161350-1-1.There have been no other events for the sterile lot referenced.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, pathology reports, progress notes, and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

• Brand Name: DISTAL FEMUR
• 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: 10186451
• MDR Text Key: 197156405
• Report Number: 3004105610-2020-00113
• 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: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: UNK_STM
• Device Lot Number: PIN 21508
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 16 YR
• Patient Weight: 50