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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_32 10° LINER HIP IMPLANT

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STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_32 10° LINER HIP IMPLANT Back to Search Results
Catalog Number UNK_JR
Device Problem Mechanical Problem (1384)
Patient Problems Pain (1994); Injury (2348)
Event Date 05/07/2019
Event Type  Injury  
Manufacturer Narrative
It was noted that the device is not available for evaluation. Should additional information become available, it will be provided in a supplemental report upon completion of the investigation. Device not returned.
 
Event Description
Revision of left hip. Rep reported the patient had pain and fluid in the joint. Infection was ruled out. Intra-operatively, surgeon noted the metal trunnion was impinging on the poly liner. There are no allegations against the head. The stem and liner were revised.
 
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Brand NameUNKNOWN_32 10° LINER
Type of DeviceHIP 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
joanne mahony
ida industrial estate
carrigtwohill NA
214532800
MDR Report Key8666334
MDR Text Key146914867
Report Number0002249697-2019-02154
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 health professional
Reporter Occupation
Type of Report Initial
Report Date 06/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/04/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK_JR
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/07/2019
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 Treatment Data
Date Received: 06/04/2019 Patient Sequence Number: 1
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