MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 36MM/+10; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 6260-9-336

Device Problems Material Fragmentation (1261); Insufficient Information (3190)

Patient Problems Edema (1820); Pain (1994); Tissue Damage (2104); Injury (2348); Reaction (2414); Device Embedded In Tissue or Plaque (3165)

Event Date 05/18/2015

Event Type  Injury  

Event Description

It was reported that there was a hardware failure.As per discussion with patient (b)(6) 2015: a revision was performed on her stryker hip (b)(6) 2015 approximately 1.5 years post primary surgery.She alleges that the surgeon noted metal fragments and a milky fluid was observed intraoperatively.

Manufacturer Narrative

Catalogue number unknown at this time.Device description reported as an unknown stryker hip.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.This report has been identified by the patient as a legal claim therefore, additional information is not available at this time.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Not returned to the manufacturer.

Manufacturer Narrative

Additional information provided in: a2, a4, b5, d1, d2, d4, g5, h4 an event regarding altr involving an metal head was reported.The event was not confirmed.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: ¿on june 2, 2011 she underwent a primary left total hip arthroplasty for a diagnosis of left avascular necrosis femoral head.An office visit of june 29, 2011 notes the x-ray showed " excellent position.Equal leg lengths" and she was to "return in two months; weightbearing as tolerated".X-ray was reported to show " excellent position, some heterotopic ossification superior acetabulum".On january 26, 2015 an mri report of the left hip has an impression of "heterogenous signal, mass along posterior proximal left femoral diaphysis.Non-specific.Solid on ultrasound.May represent.Scar.Of old hematoma or.Early particle disease".On may 4, 2015 aggressive debridement of soft tissue and a head/poly exchange of the left hip was performed for a post-operative diagnosis of "painful left total hip arthroplasty with significant soft tissue reaction to the components".The operative report notes, ".Implant.Possibly implicated.Significant trunnionosis with metal ion release and local tissue reaction.Copious amounts of thick, whitish material in bursal sack in the hip joint.Fibrotic tissue sent for frozen section.No evidence of infection.Removed the head.Black.Material along the femoral neck which suggested trunnionosis as possible etiology of.Soft tissue reaction.Cup and stem well-fixed and retained, removed the liner.Not show any significant wear or debris.Changed to a new 36/10 insert and a 36/plus-7.5 biolox head.Cleaned trunnion and got about all.Black staining off." -product history review: review of the product history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other events for this lot.Conclusions: the reported event could not be confirmed as no devices and insufficient information was provided.A review of the medical review provided stated "no examination of the explanted head and liner, and no mri images or serial x-rays other than the immediate post-operative films of the primary and post-operative revision procedures are available.No serum cobalt and chromium ion values and no pathohistology diagnostic of particle disease, either from the biopsy or subsequent surgical pathology from the revision procedure are available.Other than noting black material on the disengaged trunnion, which was easily removed and the trunnion apparently pristine enough to use with a new ceramic head, there is no evidence that the corrosive findings in the disengaged trunnion are more than would be expected after four years in situ with an extended collar head, or that the amount of corrosion was pathology and responsible for the clinical situation described." no further investigation for this event is possible at this time.If devices and/or additional information become available, this investigation will be reopened.

Event Description

It was reported that there was a hardware failure.As per discussion with patient 6/4/2015: a revision was performed on her stryker hip (b)(6) 2015 approximately 1.5 years post primary surgery.She alleges that the surgeon noted metal fragments and a milky fluid was observed intraoperatively.Update: on (b)(6) 2015 aggressive debridement of soft tissue and a head/poly exchange of the left hip was performed for a post-operative diagnosis of "painful left total hip arthroplasty with significant soft tissue reaction to the components".The operative reports notes, ".Implant.Possibly implicated.Significant trunnionosis with metal ion release and local tissue reaction.Copious amount of thick, whitish material in bursal sack in the hip joint.Fibrotic tissue sent for frozen section.No evidence of infection.Removed the head.Black.Material along the femoral neck which suggested trunnionosis as possible etiology of.Soft tissue reaction.Cup and stem well - fixed and retained, removed the liner.Not show any significant wear or debris.Cleaned trunnion and got about all.Black staining off.

• Brand Name: V40 COCR LFIT HEAD 36MM/+10
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 4827500
• MDR Text Key: 5904037
• Report Number: 0002249697-2015-01853
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: K022077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,consumer,other
• Type of Report: Initial,Followup
• Report Date: 08/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2016
• Device Catalogue Number: 6260-9-336
• Device Lot Number: MKJ3WM
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/18/2015
• Initial Date FDA Received: 06/09/2015
• Supplement Dates Manufacturer Received: 07/19/2018
• Supplement Dates FDA Received: 08/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Weight: 85