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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ALUMINA V40-FEMORAL HEAD 28MM, +0MM NK IMPLANT

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STRYKER ORTHOPAEDICS-MAHWAH ALUMINA V40-FEMORAL HEAD 28MM, +0MM NK IMPLANT Back to Search Results
Catalog Number 6565-0-128
Device Problems Mechanical Problem; Device Operates Differently Than Expected; Device Dislodged or Dislocated; Noise, Audible
Event Date 06/02/2015
Event Type  Injury  
Event Description

After the tha with trident ceramic liner and ceramic head, the patient felt pain and squeaking. The patient fell down once. Inclinatio pelvis is high. Revision surgery will be performed on (b)(6) 2015.

 
Manufacturer Narrative

The catalog number and lot code were not provided. The device was reported as alumina ceramic head v40(6565-0-xxx). A supplemental report will be submitted upon completion of the investigation.

 
Manufacturer Narrative

An event regarding audible noise and pain involving a ceramic head was reported. The event was confirmed for audible noise and dislocation. Method & results: a visual inspection was performed as part of the material analysis report. Metal transfer from likely contact with the titanium sleeve was observed on the articulating surface. The metal transfer marks on the distal side of the head are likely from the removal of the head from the stem. A metal transfer mark around the internal circumference of the female taper was observed indicating that the head was properly seated on the male trunnion of the hip stem. The material analysis report concluded that: no material or manufacturing defects were observed on the surfaces examined. Impingement damage was observed on the trident insert. The ceramic insert broke along the edge where the femoral head rode high on the insert/sleeve. Edge loading is a known contra-indicated condition for this product. A review of the provided information by a clinical consultant indicated that: cup malposition in excessive inclination has contributed to impingement between stem neck and cup rim leading to subluxation of the ceramic femoral head from the ceramic liner causing point contact with an extreme overload condition in the bearing. Ceramic fracture of the liner was the end point of failure leading to revision. Findings confirmed by mar. All devices in the reported lot were manufactured and accepted into final stock with no reported discrepancies. There have been no other similar events for the reported lot. Conclusions: a review by a clinical consultant concluded that "cup malposition in excessive inclination has contributed to impingement between stem neck and cup rim leading to subluxation of the ceramic femoral head from the ceramic liner causing point contact with an extreme overload condition in the bearing. Ceramic fracture of the liner was the end point of failure leading to revision. ". If additional information becomes available, this investigation will be reopened.

 
Event Description

After the tha with trident ceramic liner and ceramic head, the patient felt pain and squeaking. The patient fell down once. Inclinatio pelvis is high. Revision surgery will be performed on (b)(6) 2015.

 
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Brand NameALUMINA V40-FEMORAL HEAD 28MM, +0MM NK
Type of DeviceIMPLANT
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-CORK (MDR)
ida industrial estate
carrigtwohill NA
Manufacturer Contact
keyla navedo
325 corporate drive
mahwah , NJ 07430
2018315000
MDR Report Key4869725
Report Number0002249697-2015-02090
Device Sequence Number1
Product CodeLZO
Report Source Manufacturer
Source Type Other,Health Professional,HEALTH PROFESSIONAL,OTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/02/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/25/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/30/2011
Device Catalogue Number6565-0-128
Device LOT Number24163401
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/23/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/13/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/05/2007
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: 06/25/2015 Patient Sequence Number: 1
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