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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS 28/56 PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

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STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS 28/56 PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU Back to Search Results
Catalog Number 1236-2-856
Device Problem Device Dislodged or Dislocated (2923)
Patient Problems Fall (1848); Muscle Weakness (1967); Injury (2348); Joint Dislocation (2374)
Event Date 03/20/2017
Event Type  Injury  
Manufacturer Narrative
An event regarding dislocation involving a adm liner was reported. The event was confirmed through the medical review. Method & results: device evaluation and results: not performed as the reported device was not returned for evaluation. Medical records received and evaluation: a medical review was performed and concluded: the irreducible nature of the dislocation is a procedure-related design characteristic while there are no device-related factors evident from the available material. As such is this case not device-related. Procedure-related factors: cup malposition in low inclination as secondary factor. Patient-related factors patient trauma with a fall as principal failure mode. Cardiac disease and alcohol abuse may have increased the propensity to falling. Device-related factors: none. Diagnosis: patient trauma has caused a dislocation of the adm liner possibly related to additional cardiac disease where the irreducible nature of the dislocation is a procedure-related design characteristic requiring open reduction in case of dislocation. Hip abductor weakness is a secondary effect of multiple revision surgeries. Device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies. Complaint history review: review indicated there have been no other similar events for the reported lot. Conclusions: a medical review was provided and concluded that "patient trauma has caused a dislocation of the adm liner possibly related to additional cardiac disease where the irreducible nature of the dislocation is a procedure-related design characteristic requiring open reduction in case of dislocation. Hip abductor weakness is a secondary effect of multiple revision surgeries. " there was no indication of a device related issue on review of the clinical review. No further investigation is required at this time. If further relevant information becomes available or the product is returned, this investigation will be re-opened.
 
Event Description
Patient had a previous rejuvenate left hip that was revised to a securfit and adm shell and liner on (b)(6) 2012. Patient recently dislocated hip and the head and liner were revised due to disassociation of 28mm ball from adm poly liner insert. The appropriate size 56 head and head ball were reimplanted. Patient's hip was reduced and surgeon commented the abductors were compromised.
 
Manufacturer Narrative
An evaluation of the device cannot be performed as the device was retained by the patient and was not returned to the manufacturer. Additional information has been requested. Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
 
Event Description
Patient had a previous rejuvenate left hip that was revised to a securfit and adm shell and liner on (b)(6) 2012. Patient recently dislocated hip and the head and liner were revised due to disassociation of 28 mm ball from adm poly liner insert. The appropriate size 56 head and head ball were reimplanted. Patient's hip was reduced and surgeon commented the abductors were compromised.
 
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Brand NameRESTORATION ADM X3 INS 28/56
Type of DevicePROSTHESIS, 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
Manufacturer Contact
cindy chuhinko
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key6490553
MDR Text Key197093305
Report Number0002249697-2017-01254
Device Sequence Number1
Product Code MEH
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 health professional,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/19/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/18/2016
Device Catalogue Number1236-2-856
Device Lot Number36963601
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/21/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/18/2011
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: 04/13/2017 Patient Sequence Number: 1
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