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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_RECONSTRUCTIVE_PRODUCT; IMPLANT
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STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_RECONSTRUCTIVE_PRODUCT; IMPLANT Back to Search Results
Catalog Number UNK_REC
Device Problems Unstable (1667); Material Integrity Problem (2978); Naturally Worn (2988)
Patient Problem No Code Available (3191)
Event Date 11/11/2014
Event Type  Injury  
Event Description
It was reported that patient was revised on a left hip.Surgeon stated patient with instability and poly wear on x-ray.
 
Manufacturer Narrative
Catalog number unknown at this time.Device description reported as unknown insert.Additional information has been requested and if received will be submitted in a follow up report upon completion of the investigation.Not returned to manufacturer.
 
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Brand Name
UNKNOWN_RECONSTRUCTIVE_PRODUCT
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
rita intorrella
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key4309785
MDR Text Key5133629
Report Number0002249697-2014-04564
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 11/11/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/09/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNK_REC
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/11/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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) Required Intervention;
Patient Age66 YR
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