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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH LFIT MORSE TAPER HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
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STRYKER ORTHOPAEDICS-MAHWAH LFIT MORSE TAPER HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED Back to Search Results
Model Number 01-2205
Medical Device Problem Code Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code Injury (2348)
Date of Event 01/23/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
 
Event or Problem Description
Liner replacement surgery for a patient who underwent tha on (b)(6) 1998.Since the production of a 22 mm diameter liner for replacement was discontinued, 28 mm and 32 mm liners were prepared.I tried to remove the head from the stem but could not.Since no damage was observed in the implanted 22 mm diameter liner, it was washed and closed as it was.After all, nothing new implanted.
 
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Brand Name
LFIT MORSE TAPER HEAD
Common Device Name
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
MDR Report Key9728431
Report Number0002249697-2020-00362
Device Sequence Number16669391
Product Code LWJ
UDI-Device Identifier07613327016093
UDI-Public07613327016093
Combination Product (Y/N)N
Initial Reporter CountryJP
PMA/510(K) Number
K993601
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year1998
Reporter Type Manufacturer
Report Source health professional,other
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 02/19/2020
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? No
Operator of Device Health Professional
Device Model Number01-2205
Device Catalogue Number01-2205
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 01/23/2020
Initial Report FDA Received Date02/19/2020
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 Hospitalization; Required Intervention;
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