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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN +5-36MM HEAD UNK HIP IMPLANT

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STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN +5-36MM HEAD UNK HIP IMPLANT Back to Search Results
Catalog Number UNK_JR
Device Problems Corroded; Mechanical Problem; Device Dislodged or Dislocated
Event Date 07/13/2018
Event Type  Injury  
Manufacturer Narrative

An event regarding disassociation involving an unknown accolade stem was reported. The event was confirmed through clinician review of the medical records provided. Method & results: product evaluation and results: not performed as no product was returned for evaluation. Clinician review: a review of the provided medical records by a clinical consultant indicated: patient-related morbid obesity plus propensity to heterotopic ossifications in -and around the arthroplasty have contributed to an overload condition in and around the arthroplasty bearing causing excessive corrosion with metal substance loss, loss of taper lock functionality and ultimately femoral head disassociation requiring revision surgery. Product history review: not performed as no lot information was provided. Complaint history review: not performed as no lot information was provided. Conclusion: the medical review indicated patient-related morbid obesity plus propensity to heterotopic ossifications in -and around the arthroplasty have contributed to an overload condition in and around the arthroplasty bearing causing excessive corrosion with metal substance loss, loss of taper lock functionality and ultimately femoral head disassociation requiring revision surgery. No further investigation is required at this time. If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

 
Event Description

It was reported that the patient underwent a left hip arthroplasty on (b)(6) 2009. It was reported that the patient required a revision. Update: based on the medical review - patient-related morbid obesity plus propensity to heterotopic ossifications in and around the arthroplasty have contributed to an overload condition in and around the arthroplasty bearing causing excessive corrosion with metal substance loss, loss of taper lock functionality and ultimately femoral head disassociation requiring revision surgery.

 
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Brand NameUNKNOWN +5-36MM HEAD
Type of DeviceUNK HIP IMPLANT
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 Key7890076
Report Number0002249697-2018-02961
Device Sequence Number1
Product CodeLZO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,OTHER
Reporter Occupation
Type of Report Initial
Report Date 09/19/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/19/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNK_JR
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/23/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 09/19/2018 Patient Sequence Number: 1
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