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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 52MM; IMPLANT
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STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 52MM; IMPLANT Back to Search Results
Catalog Number 502-03-52D
Device Problems Mechanical Problem (1384); Failure to Advance (2524); Mechanics Altered (2984); Positioning Problem (3009)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 04/07/2015
Event Type  malfunction  
Event Description
The tritanium cup would not screw forward onto the introducer.It would screw on backwards which indicated the threads were backwards.An immediate back up was available.No delay in surgery.No adverse consequence to patient.
 
Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
 
Manufacturer Narrative
The investigation determined the likely root cause of the event to be user related damage to the first thread on the "concave" side of the cup.The damage was possibly due to either an attempted off axis impaction with only partial threading of the cup positioner/impactor into the cup or attempted off axis impaction with partial initial crossthreading.There is no indication at this time that the design, materials, or manufacturing of the subject device contributed to the event.If additional information becomes available, this investigation will be reopened.
 
Event Description
The tritanium cup would not screw forward onto the introducer.It would screw on backwards which indicated the threads were backwards.An immediate back up was available.No delay in surgery.No adverse consequence to patient.
 
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Brand Name
PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 52MM
Type of Device
IMPLANT
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer Contact
william hanna
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key4738662
MDR Text Key16564078
Report Number0002249697-2015-01403
Device Sequence Number1
Product Code LPH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K081171
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,health professional,oth
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 04/07/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/30/2019
Device Catalogue Number502-03-52D
Device Lot NumberMNHWD4
Other Device ID NumberSTERILE LOT# MSHNJ01A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received09/18/2015
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/01/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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