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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH SLIDING CORE UHMPWE, 6MM; PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME
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STRYKER GMBH SLIDING CORE UHMPWE, 6MM; PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME Back to Search Results
Catalog Number 400140
Device Problem Insufficient Information (3190)
Patient Problem No Code Available (3191)
Event Date 01/01/2015
Event Type  Injury  
Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.
 
Event Description
This pi is for the revision of the primary poly in 2015.In reviewing available information for a revision of patient's ankle, rep discovered that the implant date of the ankle construct was in 2011, and the implant date listed on the poly was 2015.Rep does not have access to any information regarding the reason for revision.Rep also reported that x-rays, medical records, and further information are not available due to hospital policy.
 
Manufacturer Narrative
The reported event that sliding core uhmpwe, 6mm was alleged of 'implant - poly - exchange' could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event such as pre- and post- operative x-rays, as well as the affected device must be available in order to determine the root cause of the complaint event.However, based on complaint history review, some potential root causes are, but are not limited to: fatigue & wear of the poly.Indeed, it is clearly stated in the ifu that: " [.] ¿ warn the patient that artificial joint replacement devices can wear out over time, and may require replacement.[.]" the selection of improper size of the poly during first implantation and/or improper placement of the device.As a reminder, the ifu states: " [.] ¿ improper selection, placement and fixation of the implant components may result in early implant failure.As in the case of all prosthetic implants, the durability of these components is affected by numerous biologic, biomechanic and other extrinsic factors which limit their service life.Accordingly, strict adherence to the indications, contraindications, precautions and warnings for this product is essential to potentially maximize service life.[.] " the subjection of the implant to high impact socks.Indeed, it is written in the ifu that: " [.] caution the patient to protect the joint replacement from unreasonable stresses and to follow the treating physician¿s instructions.In particular, warn the patient to strictly avoid high impact activities such as running and jumping.[.] " 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 the device is returned or if any additional information is provided, the investigation will be reassessed.
 
Event Description
This pi is for the revision of the primary poly in 2015.In reviewing available information for a revision of patient's ankle, rep discovered that the implant date of the ankle construct was in 2011, and the implant date listed on the poly was 2015.Rep does not have access to any information regarding the reason for revision.Rep also reported that x-rays, medical records, and further information are not available due to hospital policy.
 
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Brand Name
SLIDING CORE UHMPWE, 6MM
Type of Device
PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH  2545
MDR Report Key8006622
MDR Text Key125096489
Report Number0008031020-2018-00902
Device Sequence Number1
Product Code NTG
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 01/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/25/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date04/30/2015
Device Catalogue Number400140
Device Lot Number0942101
Was Device Available for Evaluation? No
Date Manufacturer Received12/20/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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