MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE MIDSHAFT TIBIA - TIBIAL COMPONENT LUG; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number UNK_STM

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/31/2022

Event Type  Injury  

Event Description

A patient specific implant request form was received for revision of the patient's right tibial diaphyseal replacement.Noted on the form: "screws for siw modular tibial diaphyseal replacement.The proximal connecting screw has broken and requires screw replacement." update 12sep2022: additional information provided: "there is a tibial diaphyseal replacement in situ.The proximal connecting screw has broken and requires screw replacement." update: 28nov22 clinical review confirmed the following: " the ct image provided shows that the distal screw together with the lug were broken, which lead to disengagement of the diaphyseal assembly".

Manufacturer Narrative

Reported event: an event regarding crack/fracture involving a patient specific, midshaft tibia, tibial component 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: the implant in situ was for patient specific midshaft tibial replacement which was inserted on (b)(6) 2018.The surgeon reported a broken screw for diaphyseal assembly.The ct image provided shows that the distal screw together with the lug were broken, which lead to disengagement of the diaphyseal assembly.Therefore, the radiographic review can confirm the clinical report and reason for revision.Device history review: review of the product history records indicate devices was manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for the 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, x-rays 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: MIDSHAFT TIBIA - TIBIAL COMPONENT LUG
• 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
• Manufacturer (Section G): STANMORE IMPLANTS WORLDWIDE; 210 centennial avenue; centennial park, elstree; borehamwood 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: 15922709
• MDR Text Key: 304870181
• Report Number: 3004105610-2022-00162
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: UNK_STM
• Device Lot Number: PIN 21270
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2018
• 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): Required Intervention; Hospitalization
• Patient Age: 51 YR
• Patient Sex: Male