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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE TIBIAL ROTATING HINGE; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
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STANMORE IMPLANTS WORLDWIDE TIBIAL ROTATING HINGE; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Model Number PIN 12321
Device Problems Break (1069); Fracture (1260)
Patient Problems Injury (2348); Ambulation Difficulties (2544); Inadequate Osseointegration (2646); Cancer (3262)
Event Date 10/14/2019
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.Device not returned.
 
Event Description
It has been reported that the patient will have a revision due to a broken rotating hinge.Femoral and tibial shaft components are still well fixed.The patient has a gross clinical instability and is unable to walk without crutches and lower limb orthosis.So we need to change only the rotating hinge.
 
Manufacturer Narrative
Corrected data: d6 date of implant corrected from (b)(6) 2015 to (b)(6) 2006 additional manufacturer narrative : reported event an event regarding crack/fracture of a tibial hinge involving a patient specific device was reported.The event was confirmed by medical review.Method and results: product evaluation and results: not performed as no items were returned.Clinician review: the implant in situ was for a proximal tibial replacement, which was originally inserted in 1994 and subsequently revised several times.The surgeon reported that the hinge knee has broken but the femoral and tibial stems are well fixed.The x-ray provided showed that the stem for the rotating hinge has broken at the junction of the tibial component and the piece of metal can be seen next to the tibia component.The femoral stem is well fixed, however there is some bone resorption and osteolysis at the tibial resection level, but this should not be related to the reported fracture of the stem of the hinge.Therefore, the radiographic assessment can confirm the reason for revision.Product history review: review of the product history records indicate 1 device was manufactured and accepted into final stock on 11aug2006 no reported discrepancies.Complaint history review: based on the device identification the complaint databases were reviewed from 01jan2016 to present for similar reported events regarding crack/fracture of the tibial hinge involving a patient specific proximal tibia there has been 1 other event.Conclusions: an event regarding crack/fracture of a tibial hinge involving a patient specific device was reported.The event was confirmed by medical review.The implant was in situ for 13 years.The surgeon also reported that the patient is in good health condition, although not able to walk without crutches and with lower limb orthosis.The exact cause of the event could not be determined because further information such as retrieval analysis on the explanted implant, 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
It has been reported that the patient will have a revision due to a broken rotating hinge.Femoral and tibial shaft components are still well fixed.The patient has a gross clinical instability and is unable to walk without crutches and lower limb orthosis.So we need to change only the rotating hinge.Update 06jan2020 - as per email, the tibial hinged was not revised in 2015 therefore the reported fractured tibial hinged is from pin 12321.
 
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Brand Name
TIBIAL 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
GB  WD6 3SJ
MDR Report Key9451447
MDR Text Key183567266
Report Number3004105610-2019-00130
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
PMA/PMN Number
K121029
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Type of Report Initial,Followup
Report Date 02/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/11/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberPIN 12321
Device Catalogue NumberUNK_STM
Device Lot NumberPIN 12321
Was Device Available for Evaluation? No
Date Manufacturer Received01/27/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age64 YR
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