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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 Device Operates Differently Than Expected (2913); No Apparent Adverse Event (3189)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/14/2015
Event Type  malfunction  
Event Description
It was reported that when the surgeon was putting in the cup with the da magnetic cup impactor, he went to removed the magnetic impactor and it cold welded to the cup.The surgeon was unable to remove the cup so another cup was opened.
 
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 the bolt in these events.The preliminary investigation shows these events are associated with a wide variety of shells.Therefore, the impactor bolt will be further investigated.
 
Event Description
It was reported that when the surgeon was putting in the cup with the da magnetic cup impactor, he went to removed the magnetic impactor and it cold welded to the cup.The surgeon was unable to remove the cup so another cup was opened.
 
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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 Key4766126
MDR Text Key5779017
Report Number0002249697-2015-01496
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 04/14/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/12/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/31/2020
Device Catalogue Number502-03-52D
Device Lot NumberED4197
Other Device ID NumberSTER. LOT MSHPE19A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/17/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received09/11/2015
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/19/2015
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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