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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-CORK UNKNOWN ACCOLADE II STEM HIP IMPLANT

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STRYKER ORTHOPAEDICS-CORK UNKNOWN ACCOLADE II STEM HIP IMPLANT Back to Search Results
Catalog Number UNK_SHC
Device Problems Malposition of Device (2616); Noise, Audible (3273)
Patient Problem Injury (2348)
Event Date 06/10/2019
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.
 
Event Description
It was reported that the patient's right hip was revised after patient complaint of pain and a grinding sensation. Surgeon reported that according to pre-operative scans, the shell was malpositioned. Intra-operatively, notching on the stem due to impingement with the shell was noted. The shell, an adm/ mdm liner construct, and femoral head were revised to a shell, adm/ mdm liner construct, and a metal femoral head. Rep reported that no further information will be released by the hospital or surgeon.
 
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Brand NameUNKNOWN ACCOLADE II STEM
Type of DeviceHIP IMPLANT
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-CORK
ida industrial estate
carrigtwohill NA
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-CORK
ida industrial estate
carrigtwohill NA
Manufacturer Contact
maeve junker
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key8753793
MDR Text Key149814921
Report Number0002249697-2019-02504
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
Reporter Occupation
Type of Report Initial
Report Date 07/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/02/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK_SHC
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 Received06/10/2019
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: 07/02/2019 Patient Sequence Number: 1
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