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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER. LOW PROFILE ACETAB CUP HIP IMPLANT

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STRYKER ORTHOPAEDICS-MAHWAH EXETER. LOW PROFILE ACETAB CUP HIP IMPLANT Back to Search Results
Catalog Number 0580-6-652
Device Problems Loss of Osseointegration (2408); Insufficient Information (3190)
Patient Problems Injury (2348); Inadequate Osseointegration (2646)
Event Date 10/28/2016
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
The cra reported that aseptic acetabular loosening of a right thr had been noted during a monitoring visit. The patient underwent revision surgery. The implant had been in situ for 15 years and 6 months.
 
Manufacturer Narrative
The event involves a device that is not cleared for sale in the u. S. , but similar device is commercially available in the u. S. An event regarding loosening involving an exeter shell was reported. The event was not confirmed. Method & results: -device evaluation and results: not performed as the reported device was not returned for evaluation. -medical records received and evaluation: a medical review was performed and concluded: "there is no information at all about the conditions surrounding the cup loosening. No clinical info, no x-rays or any other info. As such can this case not be solved with the current information. More info, especially x-rays would be required to solve this case. " -device history review: review indicated all devices were manufactured and accepted into final stock with no relevant reported discrepancies. -complaint history review: review indicated there have been no other similar events for the reported lot. Conclusions: a medical review was performed and concluded: "there is no information at all about the conditions surrounding the cup loosening. No clinical info, no x-rays or any other info. As such can this case not be solved with the current information. More info, especially x-rays would be required to solve this case. " if further information such as x-rays, patient history, additional operative notes and/or the device becomes available this investigation will be reopened.
 
Event Description
The cra reported that aseptic acetabular loosening of a right thr had been noted during a monitoring visit. The patient underwent revision surgery. The implant had been in situ for 15 years and 6 months.
 
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Brand NameEXETER. LOW PROFILE ACETAB CUP
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
cindy chuhinko
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key6388443
MDR Text Key69398766
Report Number0002249697-2017-00828
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeGB
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/31/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/08/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number0580-6-652
Device Lot NumberGY495691
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 Received05/05/2017
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: 03/08/2017 Patient Sequence Number: 1
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