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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 26MM -3MM V40 TRIAL HEAD PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

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STRYKER ORTHOPAEDICS-MAHWAH 26MM -3MM V40 TRIAL HEAD PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU Back to Search Results
Catalog Number 6264-8-026
Device Problems Break (1069); Fracture (1260); Difficult To Position (1467)
Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)
Event Date 01/25/2017
Event Type  malfunction  
Manufacturer Narrative
Additional information: lot #; returned to manufacturer on; device evaluated by mfg; h4 device manufacture date. An event regarding crack/fracture involving a partnership trial head was reported. The event was confirmed. Review with the material analysis engineer stated that "the device fractured due to an overload condition, as determined by the hackles on the fracture surface. " no medical records or x-rays were made available for evaluation. A device history review confirmed all devices accepted into finished goods conformed to specification. No other events were reported for the lot indicated. The investigation concluded that the reported fracture was caused by multiple overload conditions. Visual inspection indicated that the device was received with multiple small pieces fractured off. Review with the material analysis engineer stated that "device fractured due to an overload condition as indicated by the hackles observed on the fracture surface. " no further investigation is possible at this time. If additional information become available, this investigation will be reopened and re-evaluated.
 
Event Description
It was difficult to reposition for fracture, so they forced a reposition. The trial neck penetrated the trial head, and the upper part of the head was damaged due to a forced reposition. Replaced with another device and completed the procedure.
 
Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
 
Event Description
It was difficult to reposition for fracture, so they forced a reposition. The trial neck penetrated the trial head, and the upper part of the head was damaged due to a forced reposition. Replaced with another device and completed the procedure.
 
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Brand Name26MM -3MM V40 TRIAL HEAD
Type of DevicePROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
200 suhong road, sip
mahwah NJ 07430
Manufacturer Contact
timothy rice
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key6351689
MDR Text Key268673907
Report Number0002249697-2017-00635
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
PMA/PMN Number
K122853
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/01/2015
Device Catalogue Number6264-8-026
Device Lot NumberAA155159
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/07/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/15/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/31/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 02/22/2017 Patient Sequence Number: 1
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