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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; IMPLANT
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STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS 28/48; IMPLANT Back to Search Results
Catalog Number 1236-2-848
Device Problems Defective Component (2292); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Injury (2348); Joint Dislocation (2374)
Event Date 06/23/2015
Event Type  Injury  
Event Description
It was reported that the patient had virtually no abductors at time of revision and has dislocated two times since implantation.Head/mdm was removed, cup remained and a trident constrained liner was implanted.Right hip.
 
Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.
 
Manufacturer Narrative
An event regarding dislocation involving an adm liner was reported.The event was confirmed.Method & results: -device evaluation and results: not performed as the reported device was not returned for evaluation.-medical records received and evaluation: a review of the provided information by a clinical consultant concluded that: recurrent dislocation of a second-stage revision total hip arthroplasty with ¿very poor abductors¿ is not unexpected.Conversion to a constrained liner was appropriate.No examination of the explanted components is available.There is no evidence this clinical situation was related to factors of faulty component design, manufacturing, or materials.-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 events for the reported lot.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.However a review by a clinical consultant indicated that "recurrent dislocation of a second-stage revision total hip arthroplasty with ¿very poor abductors¿ is not unexpected.Additional information, including additional x-rays, follow up noted and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
 
Event Description
It was reported that the patient had virtually no abductors at time of revision and has dislocated two times since implantation.Head/mdm was removed, cup remained and a trident constrained liner was implanted.Right hip.
 
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Brand Name
RESTORATION ADM X3 INS 28/48
Type of Device
IMPLANT
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 Key4921873
MDR Text Key20123625
Report Number0002249697-2015-02367
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 Other,Health Professional,health professional,oth
Reporter Occupation Other
Type of Report Initial
Report Date 06/23/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/17/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date02/28/2020
Device Catalogue Number1236-2-848
Device Lot Number50980901
Other Device ID NumberSTER. LOT 1502M261
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received08/06/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/18/2015
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 Age67 YR
Patient Weight109
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