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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH SLIDING CORE, UHMPWE,8MM; PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED
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STRYKER GMBH SLIDING CORE, UHMPWE,8MM; PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED Back to Search Results
Model Number 400-142F
Medical Device Problem Code Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code Joint Laxity (4526)
Date of Event 06/15/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition is unknown.
 
Event or Problem Description
It was reported the patient was unstable and needed a thicker poly for stability.Revision surgery was performed.
 
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Brand Name
SLIDING CORE, UHMPWE,8MM
Common Device Name
PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
SZ  2545
MDR Report Key12188930
Report Number0008031020-2021-00311
Device Sequence Number11110142
Product Code NTG
UDI-Device Identifier00886385026947
UDI-Public00886385026947
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
P050050
Number of Events Summarized1
Summary Report (Y/N)N
Device Explanted Year2021
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/19/2021
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? Yes
Operator of Device Lay User/Patient
Device Model Number400-142F
Device Catalogue Number400142F
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 06/28/2021
Initial Report FDA Received Date07/19/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age68 YR
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