MAUDE Adverse Event Report: DEPUY DEPUY ASR HIP

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Fatigue (1849); Hair Loss (1877); Itching Sensation (1943); Pain (1994); Visual Disturbances (2140); Toxicity (2333); Depression (2361); Weight Changes (2607)

Event Date 06/04/2014

Event Type  Injury  

Event Description

Symptoms of metal toxicity began in 2013 began post-op hip replacement implanted 2009 (5 yrs), depuy asr hip, loss of appetite, extreme weight and hair loss, nighttime itching, pain in right side, fatigue, total body weakening.After er visits, urgent care clinic visits yielded no information on problem.I researched metal on metal hip replacement litigation resulting from thousands of patients having same symptoms.Found information on cobalt and chromium poisoning, diagnosis, surgical solutions that led me to think i had cobalt, chromium poisoning.Saw orthopedic surgeon who ordered mri mars, laboratory tests.Results: elevated cobalt and chromium levels: 9.0 cobalt, 6.8 chromium.Revision surgery recommended and pursued to remove hip joint toxicity source and replace total hip joint ((b)(6) 2014).Surgery made judgement to remove femoral head and replace with stryker femoral head, not to replace cup.Ineffective pt for two years with no improvement in hip strength.Surgeon went in through lateral approach, and then anterior, severing periformis that resulted in more severe limp, balance, fatigue (permanent problem).Lab test results were elevated levels of cobalt and chromium.Revision of supposed revision recommended, but couldn't handle the fear and depression.Cancelled surgery on (b)(6) 2016, went to new orthopedic surgeon.No guarantees with surgery that toxicity will be removed.Possibility of medical mistake and tissue involvement.Surgery on hold.All pertinent documentation has been submitted to medicare quality of care division ion complaint that hip was not revised, disqualified from class action lawsuit subsequently.Surgeon submitted claim from payment to medicare for total hip replacement, a false claim.Surgeon didn't follow protocol.I need another revision, and worse symptoms; falling, balance and visual difficult, depression.Limp is getting worse.Cane not enough, need walker.Diagnosis or reason for use: defective hip joint.Event abated after use stopped or dose reduced: no.

• Brand Name: DEPUY ASR HIP
• Type of Device: DEPUY ASR HIP
• Manufacturer (Section D): DEPUY
• MDR Report Key: 5938975
• MDR Text Key: 54442048
• Report Number: MW5064621
• Device Sequence Number: 1
• Product Code: JDI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/01/2016
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: BENICAR; CANE WALKER; CENTRUM; FLONASE; NORVASC; OTC MEDS: CALCIUM; RX MEDS: WELLBUTRIN 375 MG
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 74 YR
• Patient Weight: 59