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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS 28/48; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
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STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS 28/48; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU Back to Search Results
Model Number 1236-2-848
Device Problem Fracture (1260)
Patient Problem Pain (1994)
Event Date 10/13/2021
Event Type  Injury  
Event Description
It was reported that the patient's left hip was revised due to pain.Intra-operatively, it was discovered that the adm/ mdm poly liner was broken in half, and the surgeon reported that the liner was worn where the collar of the metal femoral head was articulating with the poly.A metal mdm liner, poly adm/ mdm insert, and metal femoral head were revised.Rep confirmed that no further information will be released by the hospital or surgeon.
 
Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
 
Manufacturer Narrative
An event regarding crack/fracture involving a adm liner was reported.The event of crack/fracture was confirmed by photographs provided.Method & results: -product evaluation and results: the reported device was not returned however photographs were provided for review.The photographs note the following: photograph provided showed a recently explanted liner which had fractured into 2 pieces of roughly the same size, the photograph seemed to show damage to the rim of the liner but this could not be confirmed from the photograph provided.-clinician review: a review of the provided medical information by a clinical consultant indicated: confirmation: the event cannot be confirmed without additional medical records and information.Root cause: a root cause cannot be ascertained.-product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
 
Event Description
It was reported that the patient's left hip was revised due to pain.Intra-operatively, it was discovered that the adm/ mdm poly liner was broken in half, and the surgeon reported that the liner was worn where the collar of the metal femoral head was articulating with the poly.A metal mdm liner, poly adm/ mdm insert, and metal femoral head were revised.Rep confirmed that no further information will be released by the hospital or surgeon.
 
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Brand Name
RESTORATION ADM X3 INS 28/48
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-CORK
ida industrial estate
carrigtwohill NA
EI   NA
Manufacturer Contact
joann lavatelli
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key12757567
MDR Text Key280601508
Report Number0002249697-2021-01843
Device Sequence Number1
Product Code MEH
UDI-Device Identifier04546540638977
UDI-Public04546540638977
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K093644
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date12/31/2017
Device Model Number1236-2-848
Device Catalogue Number1236-2-848
Device Lot Number42347301
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/08/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/05/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age69 YR
Patient SexFemale
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