• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN OSTEONICS STEM IMPLANTED 2002 HIP IMPLANT

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN OSTEONICS STEM IMPLANTED 2002 HIP IMPLANT Back to Search Results
Catalog Number UNK_JR
Device Problem Loss of Osseointegration (2408)
Patient Problems Pain (1994); Injury (2348); Ambulation Difficulties (2544); Inadequate Osseointegration (2646)
Event Date 05/09/2018
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 left hip was revised due to a loose stem. Examination notes provided by the rep state: "on (b)(6) [2017] a near slip and fall on her wet kitchen floor with both legs going in all sorts of different directions. She was unable to walk afterwards. Reports now pain in the deep posterior right hip area. The pain in the deep buttocks is somewhat sharp and episodic. " the stem (implanted in 2002), adapter sleeve, head, and insert (all implanted (b)(6) 2009) were revised to an exeter cemented stem with biolox ceramic head, adm/mdm construct, and additional screw.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameUNKNOWN OSTEONICS STEM IMPLANTED 2002
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
bradley curtis
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key7565333
MDR Text Key109923110
Report Number0002249697-2018-01676
Device Sequence Number1
Product Code JDL
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 06/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/04/2018
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 Received05/09/2018
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: 06/04/2018 Patient Sequence Number: 1
-
-