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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRITANIUM HEMI SOLIDBACK CUP 50MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

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STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRITANIUM HEMI SOLIDBACK CUP 50MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Catalog Number 500-03-50D
Device Problems Sticking (1597); Device Misassembled During Manufacturing /Shipping (2912); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Event Date 09/21/2015
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

Surgeon was in the process of a total hip replacement. Surgeon asked for the 50mm tritanium hemispherical shell to be opened. Upon the nurse opening tritanium shell she noticed that the inner package was stuck to the outer package lid and was peeling it open as well. We decided not to use product and instead open another equivalent shell onto the field.

 
Manufacturer Narrative

An event regarding delaminated inner tyvek lid and malpositioned implant within the packaging was reported. The event was confirmed. Method & results: -device evaluation and results: inspection of the returned device packaging confirmed the event. -medical records received and evaluation: clinician review was not performed as there is no indication that the event was related to patient factors. -device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies. -complaint history review found no other similar events for the lot. Conclusions the root cause of the event was determined to be a manufacturing non-conformance regarding the implant being malpositioned within the packaging and resulting in damage to the inner blister plastic.

 
Event Description

Surgeon was in the process of a total hip replacement. Surgeon asked for the 50mm tritanium hemispherical shell to be opened. Upon the nurse opening tritanium shell she noticed that the inner package was stuck to the outer package lid and was peeling it open as well. We decided not to use product and instead open another equivalent shell onto the field.

 
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Brand NamePRIMARY TRITANIUM HEMI SOLIDBACK CUP 50MM
Type of DevicePROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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
keyla navedo
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5150856
MDR Text Key28594236
Report Number0002249697-2015-03384
Device Sequence Number1
Product Code LPH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK081171
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 09/21/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/14/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/31/2020
Device Catalogue Number500-03-50D
Device LOT NumberN57X28
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/06/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/05/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/08/2015
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: 10/14/2015 Patient Sequence Number: 1
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