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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN X3 NEUTRAL LINER PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

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STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN X3 NEUTRAL LINER PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU Back to Search Results
Catalog Number UNK_JR
Device Problem Insufficient Information (3190)
Patient Problems Discomfort (2330); Injury (2348); Osteolysis (2377)
Event Date 11/25/2019
Event Type  Injury  
Manufacturer Narrative
It was noted that the device is not available for evaluation. If additional information is received, it will be provided in a supplemental report upon completion of the investigation. The following devices were also listed in this report: 36 +2. 5 delta v40 head; cat#: unk; lot#: unk; exeter size 150 stem; cat#: unk; lot#: unk; exeter 14mm pmma medullary canal plug; cat#: unk; lot#: unk. It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience. Not returned.
 
Event Description
It was reported that the patient's right hip was revised after patient complaint of right hip discomfort and poorly defined posterior discomfort. Office notes indicate a femoral periprosthetic osteolysis with extension, extending below the bone plugs bilaterally with endosteal scalloping and posterior cortical thinning on both sides. Possible is also cited.
 
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Brand NameUNKNOWN X3 NEUTRAL LINER
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
mahwah NJ 07430
Manufacturer Contact
brad curtis
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key9512572
MDR Text Key184887861
Report Number0002249697-2019-04080
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation Physician Assistant
Type of Report Initial
Report Date 12/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK_JR
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 Received11/25/2019
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: 12/23/2019 Patient Sequence Number: 1
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