MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 28MM +4 V40 TAPER VIT HEAD; IMPLANT

Catalog Number 6260-5-228

Device Problems Bent (1059); Metal Shedding Debris (1804); Defective Device (2588); Device Dislodged or Dislocated (2923)

Patient Problems Fall (1848); Unspecified Infection (1930); Necrosis (1971); Pain (1994); Scar Tissue (2060); Swelling (2091); Tissue Damage (2104); Confusion/ Disorientation (2553)

Event Date 03/19/2008

Event Type  Injury  

Event Description

Initial information received on (b)(6) 2013 indicated: patient försäkringen löf have sent a insurance claim to stryker with reference number (b)(4).The event took place at the (b)(6).Updated information indicated: the claim letter from lof (translated by 3rd party translation company, (b)(4)) reports that "we have received a patient injury report.He reports that he has been subjected to infection, multiple reoperations and persistent complaints and ugly scars after a total hip joint replacement on (b)(6) 2007, which was performed by the orthopaedic clinic at (b)(6).We have assessed that the infection, reoperations and their consequences are a patient injury that is covered by the patient injury act.The injury has been caused with overwhelming probability by a defect in the hip prosthesis that was surgically implanted on (b)(6) 2007.The client had surgery on (b)(6) 2007 on the left hip with hip plastic surgery accolade stem size 2 uncemented, cobalt chrome v40 head 28 mm diameter + four neck lengths, trident psl shell (cup) size 52 and insert (plastic insert) size e with 28 mm inner diameter.At follow-up on (b)(6) 2007, a very good result was noted.At return visit on (b)(6) 2008 it was determined that the patient had a confusion condition and fell a number of times after which pain appeared.Upon clinical examination nothing remarkable was found and this is now 10 months after the index operation.Upon return visit on (b)(6) 2008, pain was noted in the groin and fluctuating swelling.Deep blood clot was suspected but ruled out.During the spring of 2008 a tumour investigation was conducted based on ganglia-like change around the iliopsoas muscle, left.On (b)(6) 2009, a prosthesis luxation occurred with forward bending that was replaced into a steady condition.A new luxation occurred on (b)(6) 2009.A new luxation incident occurred where there was relatively pronounced pain, for which reason reoperation was performed on (b)(6) 2009.In the process there was a loosening of the medius muscle from greater trochanter and a metallosis in the joint.After this reoperation, infection developed leading to a catastrophic result.It can be determined that there has been metallosis.There is a secretion of metal after the index operation that may be a consequence of problems with the cone, which was discussed with (b)(4) in 2012.Regardless of whether the problems are due to the cone or not, this is with overwhelming probability a result of the prosthesis.Recently this has been observed in a number of prostheses.This is not a normal course of events.The necroses and the increased volume in the joint have with overwhelming probability caused the luxations and need for reoperation.".

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.Not returned.

Manufacturer Narrative

An event regarding dislocation involving a metal femoral head was reported.The event was confirmed.Medical records received and evaluation: clinician review of the provided records indicated: "in conclusion, no final root cause can be established based on the current information although an assumption can be made regarding an adverse mix of patient-related and procedure-related problems to have most probably made their contributions.As discussed before, a combined effect of patient-related factors in the sense of specific allergy to metal ion or other metal components that a few percent of the population would exhibit in combination with procedure-related factors in the sense of use of modular devices." conclusions: the provided medical records confirmed the reported dislocation however were insufficient to determine a root cause.Clinician review indicated the dislocation was secondary to soft tissue damage in the joint however the etiology of this soft tissue damage could not be determined.Further information such as return of explanted devices for analysis and metal allergy testing results are needed to complete the investigation for determining a root cause.

Event Description

Initial information received on (b)(6) 2013 indicated: (b)(6) have sent a insurance claim to stryker with referens number (b)(4).The event took place at the (b)(6).Updated information indicated: the claim letter from lof (translated by 3rd party translation company, (b)(6)) reports that "we have received a patient injury report.He reports that he has been subjected to infection, multiple reoperations and persistent complaints and ugly scars after a total hip joint replacement on (b)(6) 2007, which was performed by the orthopaedic clinic at (b)(6) hospital in (b)(6).We have assessed that the infection, reoperations and their consequences are a patient injury that is covered by the patient injury act.The injury has been caused with overwhelming probability by a defect in the hip prosthesis that was surgically implanted on (b)(6) 2007.The client had surgery on (b)(6) 2007 on the left hip with hip plastic surgery accolade stem size 2 uncemented, cobalt chrome v40 head 28 mm diameter + four neck lengths, trident psl shell (cup) size 52 and insert (plastic insert) size e with 28 mm inner diameter.At follow-up on (b)(6) 2007 a very good result was noted.At return visit on (b)(6) 2008 it was determined that the patient had a confusion condition and fell a number of times after which pain appeared.Upon clinical examination nothing remarkable was found and this is now 10 months after the index operation.Upon return visit on (b)(6) 2008 pain was noted in the groin and fluctuating swelling.Deep blood clot was suspected but ruled out.During the spring of 2008 a tumour investigation was conducted based on ganglia-like change around the iliopsoas muscle, left.On (b)(6) 2009 a prosthesis luxation occurred with forward bending that was replaced into a steady condition.A new luxation occurred on (b)(6) 2009 and another on (b)(6) 2009.A new luxation incident occurred where there was relatively pronounced pain, for which reason reoperation was performed on (b)(6) 2009.In the process there was a loosening of the medius muscle from greater trochanter and a metallosis in the joint.After this reoperation, infection developed leading to a catastrophic result.It can be determined that there has been metallosis.There is a secretion of metal after the index operation that may be a consequence of problems with the cone, which was discussed with aaos in 2012.Regardless of whether the problems are due to the cone or not, this is with overwhelming probability a result of the prosthesis.Recently this has been observed in a number of prostheses.This is not a normal course of events.The necroses and the increased volume in the joint have with overwhelming probability caused the luxations and need for reoperation.".

• Brand Name: 28MM +4 V40 TAPER VIT HEAD
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4021373
• MDR Text Key: 4693938
• Report Number: 0002249697-2014-03214
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K993601
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/16/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 6260-5-228
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/03/2014
• 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): Hospitalization; Required Intervention