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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 50MM IMPLANT

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STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 50MM IMPLANT Back to Search Results
Catalog Number 502-03-50D
Device Problems Bolt (741); Sticking (1597); Fitting Problem (2183); No Apparent Adverse Event (3189)
Patient Problems Injury (2348); No Known Impact Or Consequence To Patient (2692)
Event Date 06/08/2015
Event Type  Malfunction  
Event Description

During a primary hip surgery, surgeon was using the curved impactor to seat the cup. During the process the bolt got stuck in the cup and as a result the cup had to be removed as cup was well fixed but due to bolt sticking in cup, a new cup had to be implanted. Approximately a 10 minute delay in surgery as a result as a new cup had to be opened and the surgical site re-reamed. Correction per sales rep: surgical site did not have to be re-reamed. Only took out the first cup and put in new cup.

 
Manufacturer Narrative

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

 
Manufacturer Narrative

Conclusion: this event is related to a series of similar reported events where the impactor bolt cannot be dissociated from the associated shell. A capa was raised to further investigate these events. The preliminary investigation shows these events are associated with a wide variety of shells. Therefore, the impactor bolt will be further investigated. 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

During a primary hip surgery, surgeon was using the curved impactor to seat the cup. During the process the bolt got stuck in the cup and as a result the cup had to be removed as cup was well fixed but due to bolt sticking in cup, a new cup had to be implanted. Approximately a 10 minute delay in surgery as a result as a new cup had to be opened and the surgical site re-reamed. Correction per sales rep: surgical site did not have to be re-reamed. Only took out the first cup and put in new cup.

 
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Brand NamePRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 50MM
Type of DeviceIMPLANT
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 Key4888308
MDR Text Key6069941
Report Number0002249697-2015-02184
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 Other,Health Professional,HEALTH PROFESSIONAL,OTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/08/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/02/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/31/2020
Device Catalogue Number502-03-50D
Device LOT NumberW64V8K
OTHER Device ID NumberSTER. LOT MSHPJ12A
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/22/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/11/2015
Was Device Evaluated By Manufacturer? No
Date Device Manufactured05/13/2015
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: 07/02/2015 Patient Sequence Number: 1
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