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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNITRAX C-TAPER SLEEVE +0MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL
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STRYKER ORTHOPAEDICS-MAHWAH UNITRAX C-TAPER SLEEVE +0MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL Back to Search Results
Catalog Number 6942-7-065
Medical Device Problem Code Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 09/18/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Not returned to the manufacturer.
 
Event or Problem Description
Taper sleeve would not stay engaged to the trunnion.
 
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Brand Name
UNITRAX C-TAPER SLEEVE +0MM
Common Device Name
PROSTHESIS, HIP, HEMI-, FEMORAL, METAL
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
MDR Report Key7969800
Report Number0002249697-2018-03378
Device Sequence Number11197429
Product Code KWL
UDI-Device Identifier07613327013467
UDI-Public07613327013467
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K992570
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional,other
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 10/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date06/30/2023
Device Catalogue Number6942-7-065
Device Lot Number65895008
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/18/2018
Initial Report FDA Received Date10/16/2018
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 Other;
Patient Age85 YR
Patient Weight84
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