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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN 5.5/127 DEGREE ACCOLADE TMZF PLUS STEM HIP IMPLANT

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STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN 5.5/127 DEGREE ACCOLADE TMZF PLUS STEM HIP IMPLANT Back to Search Results
Catalog Number UNK_SHC
Device Problems Positioning Problem (3009); Noise, Audible (3273)
Patient Problems Injury (2348); Reaction (2414)
Event Date 05/07/2007
Event Type  Injury  
Manufacturer Narrative
It was noted that the device is not available for evaluation. Additional information has been requested. Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
 
Event Description
It was reported through a research article: a (b)(6) man who had undergone staged bilateral tha presented with squeaking of the right hip while walking. Symptoms had been present for 2 months and had progressed to a sensation of clunking one week prior to the office visit. The tha on the right side was done 6 years ago and examination showed no shortening or neurovascular deficit. The patient had normal range of motion with an audible clunk that was not associated with pain. He was not playing any sports and denied any injury. His weight, height, and body mass index were (b)(6), respectively. Radiographs showed a relative change of alignment between the head and neck compared with previous radiographs. The change was subtle and not appreciated on an initial radiograph obtained when the patient was seen by a midlevel provider. A month later, when the patient was seen by the operating surgeon, the findings were more obvious. Laboratory studies showed a normal erythrocyte sedimentation rate and c-reactive protein level.
 
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Brand NameUNKNOWN 5.5/127 DEGREE ACCOLADE TMZF PLUS STEM
Type of DeviceHIP IMPLANT
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-CORK
ida industrial estate
carrigtwohill NA
Manufacturer Contact
keyla colon
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key6285961
MDR Text Key66031663
Report Number0002249697-2017-00298
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
Type of Report Initial
Report Date 01/30/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/30/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK_SHC
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 Received12/29/2016
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: 01/30/2017 Patient Sequence Number: 1
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