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

Catalog Number UNK_JR

Device Problem Metal Shedding Debris (1804)

Patient Problems Inflammation (1932); Pain (1994); Synovitis (2094); Osteolysis (2377); Reaction (2414)

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".

• Brand Name: UNKNOWN 32/PLUS 5 HEAD
• Type of Device: 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: juana hiciano ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7476837
• MDR Text Key: 107065604
• Report Number: 0002249697-2018-01273
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• 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 Received: 05/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_JR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/02/2018
• 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 Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69
• Patient Weight: 66