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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH SLIDING CORE UHMPWE, 7MM; PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED
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STRYKER GMBH SLIDING CORE UHMPWE, 7MM; PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED Back to Search Results
Catalog Number 400141
Device Problems Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Failure of Implant (1924); Pain (1994); Swelling (2091); Injury (2348); Ambulation Difficulties (2544)
Event Date 10/14/2019
Event Type  Injury  
Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
 
Event Description
As reported: "films show poly failure." as per progress note: ".He was vacuuming and felt pain.He has had increased pain and swelling since then.He is currently on crutches.He has had an acute increase in his pain." revision surgery is planned.
 
Manufacturer Narrative
The reported event could be confirmed.In the case presented a patient had been treated with star in 2014.On (b)(6) 2019, the patient had to be revised as they were having pain in the their ankle and could not walk without crutches.Indeed, the device inspection revealed the following: the component is fractured in two halves perpendicularly to the sliding groove.The x-ray thread on the medial side of the device is visible and has been deformed.A large zone of the sliding core is highly deformed, most probably due to an unbalanced repartition of the mechanical forces on the implant during the time of implantation.This discrepancy in mechanical loading could be one of the reasons the material broke due to fatigue "faster".Since the operative reports and x-rays were provided, the opinion of stryker's medical expert was requested.After analysis of the documents, they could confirm the breakage of the sliding core but without finding a specific root cause.The x-rays post operatively are necessary to do so.The ankle joint with a star implant is a complex mechanism of motion and is dependent upon proper alignment.A malalignment to this ankle joint complex system affects the interactions between metal and poly and causes degradation of the poly and visual wear on the metal.As a conclusion, according to our medical expert, no obvious clinical or surgical root cause can be noticed from the documents provided.However, patient related factors could explain the accelerated fatigue and wear of the device.Indeed, even a slight inadequate repartition of mechanical forces could have affected the devices lifespan.Furthermore, it is important to state that the implant is not supposed to withstand stresses as much as a normal bone.Based on the provided information alone, a specific root cause could not be determined.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the investigation report will be updated.
 
Event Description
As reported: "films show poly failure." as per progress note: ".He was vacuuming and felt pain.He has had increased pain and swelling since then.He is currently on crutches.He has had an acute increase in his pain." revision surgery is planned.
 
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Brand Name
SLIDING CORE UHMPWE, 7MM
Type of Device
PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH  2545
MDR Report Key9288611
MDR Text Key178644299
Report Number0008031020-2019-01600
Device Sequence Number1
Product Code NTG
Combination Product (y/n)N
PMA/PMN Number
P050050
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 01/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/06/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date08/31/2018
Device Catalogue Number400141
Device Lot Number1317090
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/21/2019
Date Manufacturer Received12/17/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age67 YR
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