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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 50MM NO 1 IMPLANT

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STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 50MM NO 1 IMPLANT Back to Search Results
Catalog Number 0580-1-501
Device Problems Fracture (1260); No Apparent Adverse Event (3189)
Patient Problems Crushing Injury (1797); No Code Available (3191)
Event Date 07/29/2015
Event Type  Injury  
Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

 
Event Description

The sales rep has reported on behalf of the customer that a patient has had to undergo revision surgery on an alumina ceramic head (36), an exeter stem and a liner due to an industrial sized oil tank falling on the patient and crushing the alumina head. The sales rep has reported that the shell did not need to be revised. The sales rep has reported that due to the state of the alumina head, it cannot be returned for further investigation. The original devices were implanted in 2011. Update july 30, 2015: the customer has reported that they had to replace the acetabular insert, the femoral head and exchange the stem for an in-cement revision short stem as there was considerable damage to the trunion on the stem. Revision surgery date was (b)(6) 2015.

 
Manufacturer Narrative

Based on the provided information, the product reported in this investigation did not contribute to the event. It was reported that a patient underwent revision surgery on an alumina ceramic head (36), an exeter stem and a liner due to an industrial sized oil tank falling on the patient and crushing the alumina head. It was further reported that the surgeon performed an exchange of the stem for an in-cement revision short stem as there was considerable damage to the trunnion on the stem. The material analysis report confirmed that the scratching and deformation on the trunnion of the exeter stem is consistent with the reported event.

 
Event Description

The sales rephas reported on behalf of the customer that a patient has had to undergo revision surgery on an alumina ceramic head (36), an exeter stem and a liner due to an industrial sized oil tank falling on the patient and crushing the alumina head. The sales rep has reported that the shell did not need to be revised. The sales rep has reported that due to the state of the alumina head, it cannot be returned for further investigation. The original devices were implanted in 2011. Update july 30, 2015: the customer has reported that they had to replace the acetabular insert, the femoral head and exchange the stem for an in-cement revision short stem as there was considerable damage to the trunnion on the stem. Revision surgery date was (b)(6) 2015.

 
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Brand NameEXETER V40 STEM 50MM NO 1
Type of DeviceIMPLANT
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
sandra spokane
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5031360
MDR Text Key24086450
Report Number0002249697-2015-02782
Device Sequence Number1
Product Code LPH
Combination Product (Y/N)N
Reporter Country CodeUK
PMA/PMN NumberK121308
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 07/29/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/26/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/31/2016
Device Catalogue Number0580-1-501
Device LOT NumberG3142922
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/21/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/29/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/12/2011
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: 08/26/2015 Patient Sequence Number: 1
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