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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 54MM IMPLANT

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STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 54MM IMPLANT Back to Search Results
Catalog Number 502-03-54E
Device Problems Loose or Intermittent Connection; Insufficient Information
Event Date 07/06/2015
Event Type  Injury  
Event Description

It was reported that the patient had a acetabular cup hip revision for a loosening cup.

 
Manufacturer Narrative

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

 
Manufacturer Narrative

Additional devices added to this event: catalog: 6570-0-132, device description: delta v-40 ceramic head 32/0 lot:47517401. Catalog: 2030-6520-1, device description: 6. 5 cancellous bone screw 20mm lot: mjah1t. Catalog: unk_shc, device description: unknown acolade stem lot:unknown. Catalog: 623-10-32e, device description: trident 10° x3 insert 32mm id lot:47617801. An event regarding cup loosening involving a tritanium shell was reported. Shell loosening and infection were confirmed. Method & results: -device evaluation and results: there was no evidence of bone ongrowth. The damage on the coating surface was likely explantation damage. A dimensional inspection was performed. There was no evidence of a dimensional issue. -medical records received and evaluation: a medical was performed and concluded that: "post revision surgery most likely a low-grade infection developed to contribute to tritanium cup loosening requiring second revision in 2015 but there is inadequate information to conclude this with any certainty. " -device history review: all devices in the reported lot were manufactured and accepted into final stock with no reported discrepancies. -complaint history review: there have been no other similar events for the reported lot. There was one other similar event for the reported sterile lot. Conclusions: a medical review was performed and concluded that the likely cause of the loosening was related to a low-grade infection and that there was no evidence of a device related issue. No further investigation is required at this time. If further relevant additional information becomes available, this investigation will be reopened.

 
Event Description

It was reported that the patient had an acetabular cup hip revision for a loosening cup.

 
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Brand NamePRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 54MM
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
william hanna
325 corporate drive
mahwah , NJ 07430
2018315000
MDR Report Key4943948
Report Number0002249697-2015-02484
Device Sequence Number1
Product CodeLPH
Report Source Manufacturer
Source Type Other,Health Professional,HEALTH PROFESSIONAL,OTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/06/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/27/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/30/2018
Device Catalogue Number502-03-54E
Device LOT Number44168401
OTHER Device ID NumberSTER. LOT 1306GCM
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/17/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/17/2015
Was Device Evaluated By Manufacturer? No
Date Device Manufactured06/12/2013
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: 07/27/2015 Patient Sequence Number: 1
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