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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 60MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

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STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 60MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Catalog Number 502-03-60F
Device Problems Connection Problem (2900); No Apparent Adverse Event (3189)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 10/19/2015
Event Type  Malfunction  
Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

 
Event Description

After proper acetabular window trialing was performed, the 60mm tritanium hemispherical cluster hole cup was opened on to the sterile field. The surgical tech opened the inner packing and went to engage the "screw in" bolt from the direct superior offset insert handle. The magnetic screw in bolt would not engage into the tritanium shell. After a few times trying to get the initial threads started into the cup, it would not engage. After consulting with the surgeon and surgical tech, the doctor gave the go ahead to open up another 60mm tritanium and inserted it with no problem.

 
Manufacturer Narrative

An event regarding an assembly issue with a magnetic screw in bolt into a tritanium shell was reported. The event was not confirmed. Conclusions: the event was not confirmed. Dimensional and functional inspection noted that the thread was fully functional. Based on the provided information, the product reported in this investigation did not contribute to the event. No further investigation is required at this time. If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

 
Event Description

After proper acetabular window trialing was performed, the 60mm tritanium hemispherical cluster hole cup was opened on to the sterile field. The surgical tech opened the inner packing and went to engage the "screw in" bolt from the direct superior offset insert handle. The magnetic screw in bolt would not engage into the tritanium shell. After a few times trying to get the initial threads started into the cup, it would not engage. After consulting with the surgeon and surgical tech, the doctor gave the go ahead to open up another 60mm tritanium and inserted it with no problem.

 
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Brand NamePRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 60MM
Type of DevicePROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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
beverly lima
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5230641
MDR Text Key31657389
Report Number0002249697-2015-03785
Device Sequence Number1
Product Code LPH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK143085
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/20/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/17/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/31/2020
Device Catalogue Number502-03-60F
Device LOT Number850KH7
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/01/2015
Was Device Evaluated By Manufacturer? No
Date Device Manufactured01/30/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 11/17/2015 Patient Sequence Number: 1
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