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

Catalog Number UNK_STM

Device Problems Degraded (1153); Fracture (1260)

Patient Problem Injury (2348)

Event Date 04/01/2020

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.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.Device not returned.

Event Description

As reported: "[surgeon] has a patient whom he did a custom right knee on 4 or 5 years ago and the axle has broken.He needs to revise this asap and therefore needs to know the size of the component, as if extra small we will need the spare parts sending for this size." update 02/april/2020 wg: as reported by surgeon: "the axle is intact.The bit that is broken is the rotating peg that goes into the tibial poly.So i think i should change: poly insert into tibia, rotating metal bit, bumper pad, axle and bushings.".

Manufacturer Narrative

Reported event.An event regarding damage (bending) involving a tibial hinge component for a patient specific distal femoral replacement was reported.The event was not confirmed.Method and results: product evaluation and results: not performed as no items were returned.Clinician review: the implant in situ was for a distal femoral replacement which was inserted on (b)(6) 2016.The surgeon reported a rotating peg that goes into the tibial poly tray was broken.The radiographic images provided doesn¿t show the broken peg which might be covered by other metal components.However, the tibial peg (rotating hinge stem) that inserted into the tibial plateau may be bent.A retrieved implant may be able to confirm this.Therefore, the radiographic assessment cannot confirm the broken peg but can suggest the peg may be bent.Product history review: review of the product history records indicate (b)(4) was manufactured and accepted into final stock on 01mar2016 with no reported discrepancies.Complaint history review: there have been no other events.Conclusions: an event regarding damage (bending) involving a tibial hinge component for a patient specific distal femoral replacement was reported.The event was not confirmed.The exact cause of the event could not be determined because further information such as analysis on the retrieved implant and the primary operative report as well as patient history and follow up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time as no devices and/or insufficient information was received by siw.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be re-opened.

Event Description

As reported: "[surgeon] has a patient.Whom he did a custom right knee on 4 or 5 years ago and the axle has broken.He needs to revise this asap and therefore needs to know the size of the component, as if extra small we will need the spare parts sending for this size." update 02/april/2020 (b)(6) : as reported by surgeon: "the axle is intact.The bit that is broken is the rotating peg that goes into the tibial poly.So i think i should change: poly insert into tibia, rotating metal bit, bumper pad, axle and bushings." update 11aug2020 - after the revision, it was observed that it was not the axle that had broken, the rotating component was bent almost to breaking on the underside where the metal goes into the polyethylene on the tibia.The surgeon replaced the rotating component, bushes, axle, poly tibial insert and bumper.The femoral and tibial components were well fixed so the surgeon was happy to leave these in situ.

• Brand Name: DISTAL FEMORAL REPLACEMENT - ROTATING HINGE
• 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: 10009298
• MDR Text Key: 189983359
• Report Number: 3004105610-2020-00088
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: K121029
• 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: 10/06/2020

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: 08/31/2016
• Device Catalogue Number: UNK_STM
• Device Lot Number: PIN19948
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/01/2020
• Initial Date FDA Received: 04/29/2020
• Supplement Dates Manufacturer Received: 09/11/2020
• Supplement Dates FDA Received: 10/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR