MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN ADM LINER; HIP IMPLANT

Catalog Number UNK_REC

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Fatigue (1849); Ambulation Difficulties (2544)

Event Date 06/04/2014

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Additional information has been requested.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

It was reported via medwatch report #mw5064621: 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 2014.Surgeon 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 in 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.

Manufacturer Narrative

An event regarding off label use and concerns of elevated cobalt /chrome involving an unknown adm liner was reported.Conclusions: the reported event involves an off label use of a adm liner and competitor implants.The adm liner is a polyethylene based material and cobalt/chrome is not part of the material make up.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

It was reported via medwatch report #mw5064621: 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 2014.Surgeon 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 in 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.

• Brand Name: UNKNOWN ADM LINER
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NJ NA
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6530760
• MDR Text Key: 73972693
• Report Number: 0002249697-2017-01405
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 09/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_REC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/25/2017
• 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: 72 YR
• Patient Weight: 60