MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE PROXIMAL TIBIA REPLACEMENT (INTERNAL) - TIBIAL STEM; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number UNK_STM

Device Problem Loss of Osseointegration (2408)

Patient Problems Bone Fracture(s) (1870); Injury (2348); Inadequate Osseointegration (2646); Cancer (3262)

Event Date 02/12/2020

Event Type  Injury  

Manufacturer Narrative

The reported device is similar to a device approved for compassionate use in the united states.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.Device not returned.

Event Description

A patient specific prescription form was received with note "failed [right] distal segment and collapse of bone.Need longer distal section from diaphyseal implant.Disengage the current one and replace." update 16apr20 from x ray review: clinician stated "the distal stem is misaligned with the tibial cavity with gross radiolucent lines around the stem".

Event Description

A patient specific prescription form was received with note "failed [right] distal segment and collapse of bone.Need longer distal section from diaphyseal implant.Disengage the current one and replace." update (b)(6) 2020 from x ray review: clinician stated "the distal stem is misaligned with the tibial cavity with gross radiolucent lines around the stem".

Manufacturer Narrative

Reported event: an event regarding loosening involving a patient specific, proximal tibia, tibial stem 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 x-rays by a clinical consultant indicated: the implant in situ was for a proximal tibial replacement which was inserted on (b)(6) 2018.The surgeon reported a failed distal segment and bone collapse.The ct scan provided showed that the distal stem is misaligned with the tibial cavity with gross radiolucent lines around the stem.A mild bone fracture was observed at resection level on the medial side.Therefore, the radiographic review can confirm the reason for revision.Device history review: review of the product history records indicates 1 device was manufactured and accepted into final stock on (b)(6) 2018 with no reported discrepancies.Complaint history review: there have been 3 other events.

Event Description

A patient specific prescription form was received with note "failed [right] distal segment and collapse of bone.Need longer distal section from diaphyseal implant.Disengage the current one and replace." update (b)(6) 2020 from x ray review: clinician stated "the distal stem is misaligned with the tibial cavity with gross radiolucent lines around the stem".

Manufacturer Narrative

The investigation was re-opened following additional information from the surgeon.  this report is being submitted to document the updated conclusion following the additional information received.Reported event: an event regarding loosening involving a patient specific, proximal tibia, tibial stem 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 x-rays by a clinical consultant indicated: the implant in situ was for a proximal tibial replacement which was inserted on (b)(6) 2018.The surgeon reported a failed distal segment and bone collapse.The ct scan provided showed that the distal stem is misaligned with the tibial cavity with gross radiolucent lines around the stem.A mild bone fracture was observed at resection level on the medial side.Therefore, the radiographic review can confirm the reason for revision.Device history review: review of the product history records indicates 1 device was manufactured and accepted into final stock on 16 oct 2018 with no reported discrepancies.Complaint history review: there have been 3 other events.Conclusion: the surgeon confirmed that likely multiple issues led to the lack of bone ingrowth (reduced initial implant : bone fixation), but did not believe the implant failed per se, but rather the construct around it did.The surgeon noted two events as likely contributing factors to the lack of bone ingrowth, a patient injury from a fall and chemotherapy treatment.The surgeon also noted that patient did have a deep joint infection "but they was unconvinced as to the influence of this".The exact cause of the event could not be determined because insufficient information was provided.Additional information including operative 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: PROXIMAL TIBIA REPLACEMENT (INTERNAL) - TIBIAL STEM
• 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: 10055994
• MDR Text Key: 191693680
• Report Number: 3004105610-2020-00089
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: UNK_STM
• Device Lot Number: PIN 21594
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/16/2020
• Initial Date FDA Received: 05/14/2020
• Supplement Dates Manufacturer Received: 05/22/2020; 10/02/2020
• Supplement Dates FDA Received: 06/16/2020; 10/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR