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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN 32/PLUS 5 HEAD HIP IMPLANT

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STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN 32/PLUS 5 HEAD HIP IMPLANT Back to Search Results
Catalog Number UNK_JR
Device Problem Metal Shedding Debris
Event Date 08/02/1994
Event Type  Injury  
Manufacturer Narrative

Method & results: product evaluation and results: visual, dimensional, functional inspection, and material analysis were not performed as the item was not returned. Clinician review: a review of the provided medical records and x-rays by a clinical consultant indicated: ¿failure of biologic fixation nineteen years status-post total hip arthroplasty with osteolysis secondary to wear through of the polyethylene with metallosis is not unexpected. Persistent groin pain and a second revision four years later after seating the revision acetabular component on allograft in a compromised host acetabulum is also not unexpected. The second revision was to a competitor component, which subsequently was infected. From the available clinical information there is no evidence of implant related factors. ¿ product history review: a product history review could not be performed as the device was not properly identified. Complaint history review: a complaint history review could not be performed as the device was not properly identified conclusions: the reported event regarding wear was confirmed based on the clinician¿s review. The clinician stated, ¿failure of biologic fixation nineteen years status-post total hip arthroplasty with osteolysis secondary to wear through of the polyethylene with metallosis is not unexpected. Persistent groin pain and a second revision four years later after seating the revision acetabular component on allograft in a compromised host acetabulum is also not unexpected. ¿ the exact root could not be determined at this time. If further information becomes available the complaint will be reopened and re-evaluated.

 
Event Description

Medical review: ¿on (b)(6) 2009 a revision of the left acetabular component and femoral head with an allograft to the acetabulum was performed for a diagnosis of failed left acetabulum with osteolysis. The operative report notes "marked black metal-on-metal synovitis, entire thigh and hip" and "an extensive synovectomy; complete wear through the poly, the head was articulating with metal in dome with wear away of one of the acetabular screws". The report further notes, "cup was loose, removed with osteotomes. Posterior column, erosion through to sciatic notch and erosion into pubis and ischium, filled with 60 ml of allograft".

 
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Brand NameUNKNOWN 32/PLUS 5 HEAD
Type of DeviceHIP 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
juana hiciano
325 corporate drive
mahwah , NJ 07430
2018315000
MDR Report Key7476837
Report Number0002249697-2018-01273
Device Sequence Number1
Product CodeLZO
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial
Report Date 05/01/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/01/2018
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 Received04/02/2018
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: 05/01/2018 Patient Sequence Number: 1
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