MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN COCR LFIT HEAD; HIP IMPLANT

Catalog Number UNK_JR

Device Problems Corroded (1131); Insufficient Information (3190)

Patient Problems Edema (1820); Foreign Body Reaction (1868); Inflammation (1932); Necrosis (1971); Pain (1994); Tissue Damage (2104); Discomfort (2330); Injury (2348); Reaction (2414); Ambulation Difficulties (2544)

Event Date 03/20/2014

Event Type  Injury  

Manufacturer Narrative

The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.

Event Description

The solicitor's letter alleges that as a result of hip replacement surgery the metal on poly hip implant caused side-effects which included the production of toxins which entered the patient's blood stream causing severe tissue necrosis.The patient alleges that she has suffered constant pain and discomfort between implantation on (b)(6) 2010 and explantation on (b)(6) 2014.The solicitor's letter reports the following medical history: following right hip replacement surgery on (b)(6) 2010 the patient was implanted with a stryker metal on poly hip replacement involving a cocr lfit head with an accolade stem.In (b)(6) 2011, blood metal ion tests were carried out following previous left hip replacement surgery.The chromium level was reported to be within normal limits.The cobalt was above the recommended upper limit but short on the level where any action would be required.On (b)(6) 2013, a patient review found right lateral hip pain extending into the buttock.Movement of the hip was restricted.On (b)(6) 2013 a tear of the right gluteus medius tendon associated with soft tissue and bone marrow oedema.By (b)(6) 2014, the patient was walking with a profound limp.Examination showed a marked irritability in the right hip joint as well as half a centimeter of true shortening in the right lower limb.On (b)(6) 2014, revision surgery was undertaken.The patient was found to have severe necrosis which the solicitor alleges to be the result of a corrosion of products, generated between the cobalt chrome femoral head and the trunnion of the titanium femoral stem.The femoral head was removed and replaced with a ceramic component.The acetabular liner was also revised using a thicker wall polyethylene insert.

Manufacturer Narrative

Corrected data: it was discovered that the selection for outcomes attributed to adverse event was inadvertently missed during the submission of the initial report.Outcomes attributed to adverse event has been updated with the appropriate information.

Event Description

The solicitor's letter alleges that as a result of hip replacement surgery the metal on poly hip implant caused side-effects which included the production of toxins which entered the patient's blood stream causing severe tissue necrosis.The patient alleges that she has suffered constant pain and discomfort between implantation on (b)(6) 2010 and explantation on (b)(6) 2014.The solicitor's letter reports the following medical history: following right hip replacement surgery on (b)(6) 2010 the patient was implanted with a stryker metal on poly hip replacement involving a cocr lfit head with an accolade stem.In (b)(6) 2011, blood metal ion tests were carried out following previous left hip replacement surgery.The chromium level was reported to be within normal limits.The cobalt was above the recommended upper limit but short on the level where any action would be required.On (b)(6) 2013, a patient review found right lateral hip pain extending into the buttock.Movement of the hip was restricted.On (b)(6) 2013 a tear of the right gluteus medius tendon associated with soft tissue and bone marrow oedema.By (b)(6) 2014, the patient was walking with a profound limp.Examination showed a marked irritability in the right hip joint as well as half a centimeter of true shortening in the right lower limb.On (b)(6) 2014, revision surgery was undertaken.The patient was found to have severe necrosis which the solicitor alleges to be the result of a corrosion of products, generated between the cobalt chrome femoral head and the trunnion of the titanium femoral stem.The femoral head was removed and replaced with a ceramic component.The acetabular liner was also revised using a thicker wall polyethylene insert.

• Brand Name: UNKNOWN COCR LFIT 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: alessandra chavez ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 6793140
• MDR Text Key: 82654902
• Report Number: 0002249697-2017-02480
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: GB
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2017
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/23/2020
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Age: 63 YR