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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 Material Integrity Problem (2978); Scratched Material (3020); Appropriate Term/Code Not Available (3191)
Patient Problem Joint Dislocation (2374)
Event Date 07/28/2015
Event Type  Injury  
Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
 
Event Description
It was reported by the surgeon that the patient had a number of dislocations treated with closed reductions.The surgeon chose to revise this patient and use a constrained liner.While revising this patient he discovered that the 28mm v40 biolox head disassociated from the 42mm x3 poly.He removed the 28mm v40 biolox head from the trunnion and the mdm metal liner from the cup.Dr (b)(6) then implanted a trident 0degree constrained liner and a v40 22.2 x 3 head.
 
Manufacturer Narrative
An event regarding disassociation involving an adm liner was reported.The event was not confirmed.Method & results: -device evaluation and results: visual inspection: there is damages observed on the adm liner potentially caused during implantations and dislocations.Dimensional inspection: the device was dimensionally inspected as per igs-0029573.The part has inspected and failed on inner sphere, inner sphere position and b diameters.The b dimension had been 100% inspected in process and passed.-device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.A review of the dhr confirms that all devices were inspected and found compliant to specification at the time of manufacture.-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.Additional information, including operative reports, progress notes, x-rays are needed to fully investigate the event.If further information becomes available , this investigation will be re-opened.
 
Event Description
It was reported by the surgeon that the patient had a number of dislocations treated with closed reductions.The surgeon chose to revise this patient and use a constrained liner.While revising this patient he discovered that the 28mm v40 biolox head disassociated from the 42mm x3 poly.He removed the 28mm v40 biolox head from the trunnion and the mdm metal liner from the cup.Dr (b)(6) then implanted a trident 0degree constrained liner and a v40 22.2 x 3 head.
 
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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
ida industrial estate
carrigtwohill NA
Manufacturer Contact
keyla navedo
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5027619
MDR Text Key23942284
Report Number0002249697-2015-02776
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 Physician
Type of Report Followup
Report Date 07/28/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/25/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date05/31/2019
Device Catalogue Number1236-2-848
Device Lot Number47921701
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/29/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/26/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/20/2014
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 Age84 YR
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