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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ALL POLY CONSTRAINED INSERT 52MM; PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER
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STRYKER ORTHOPAEDICS-MAHWAH ALL POLY CONSTRAINED INSERT 52MM; PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER Back to Search Results
Catalog Number 69-2852
Device Problems Break (1069); Fracture (1260); Material Integrity Problem (2978)
Patient Problems Injury (2348); No Code Available (3191)
Event Date 02/01/2016
Event Type  Injury  
Manufacturer Narrative
When completed, the evaluation summary will be submitted in a supplemental report.
 
Event Description
The customer reported that a patient luxated the trident all poly constrained acetabular insert between outer and inner bearing.Primary operation was in (b)(6) of 2011.An all poly constrained cup with an exeter was placed in 2011.Doctor mentioned pre-operative that a fracture of the titanium locking ring was visible on the x-ray.This concerns the left hip.
 
Manufacturer Narrative
An event regarding luxation and crack/fracture of the locking ring involving all poly constrained insert 52mm was reported.The provided x-rays confirmed the fracture of the locking ring.Method & results: device evaluation and results: mar concluded: damage was observed on the insert was consistent with explantation damage.Damage to the locking ring was consistent with impingement.No material or manufacturing defects were observed on the surfaces examined.Medical records received and evaluation: a review of the provided medical records and/or x-rays by a clinical consultant indicated: there is no obvious malposition of the component placement on x-rays observed.No material or manufacturing defects were observed on the surfaces examined in the material analysis report.It is reasonable to believe that the poor condition of the tissues supporting the implant lead to its early failure.Device history review: a device history review confirmed all devices accepted into finished goods conformed to specification.Complaint history review: no other events were reported for the lot indicated.Conclusions: the investigation concluded that the reported luxation and fracture of the locking ring was caused by the patient's insufficient soft tissue constraint.If additional information becomes available, this investigation will be reopened.
 
Event Description
The customer reported that a patient luxated the trident all poly constrained acetabular insert between outer and inner bearing.Primary operation was in (b)(6) of 2011.An all poly constrained cup with an exeter was placed in 2011.Doctor mentioned pre-operative that a fracture of the titanium locking ring was visible on the x-ray.This concerns the left hip.
 
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Brand Name
ALL POLY CONSTRAINED INSERT 52MM
Type of Device
PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER
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 colon
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5432176
MDR Text Key38080362
Report Number0002249697-2016-00406
Device Sequence Number1
Product Code KWZ
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K061654
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/01/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/11/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/31/2015
Device Catalogue Number69-2852
Device Lot NumberMJRRRV
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/21/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/19/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/16/2010
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) Required Intervention;
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