MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE TMZF HIP STEM #4; IMPLANT

Catalog Number 6020-0435

Device Problem Defective Device (2588)

Patient Problems Arthritis (1723); Aspiration/Inhalation (1725); Pneumonia (2011); Toxicity (2333)

Event Date 09/29/2014

Event Type  Injury  

Event Description

Pursuant to dr.(redacted) correspondence, several years ago he successfully had a stryker hip implant placed in his left leg.After approximately one and half years, he began to present signs of loss of balance.Later, he stated that he began to present various more severe symptoms of the following: open lesions on his legs & thorax, lungs began to deteriorate, recurring bouts of pneumonia, epiglottis began to fail to close properly and allowing food & liquid to get into his lungs, permanent feeding tube and tracheotomy was placed in, and he now relies on a breathing machine at night, and he takes several medications.He has since learned that the type of implant that was used on him was defective.He alleges that the implant was made in part from cobalt metal, and was made in such a way that the cobalt from the implant was gradually poisoning dr.(redacted) body.Dr.(redacted) original implant has been removed, and a new one has been implanted.Dr.(redacted) states that he recently developed severe arthritis.Dr.(redacted) states that his cobalt levels before his replacement surgery were measured at 12.8, and six months after the defected implant was removed they have dropped down to just under 1.0.Dr.(redacted) takes issue with the fact that stryker failed to inform the recipients of these devices long after they knew about their potential problems.

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available, the evaluation summary will be submitted in a supplemental report.

Manufacturer Narrative

An event regarding abnormal cobalt levels involving an accolade stem was reported.Conclusion: the subject device is manufactured from materials which do not contain cobalt.As such, there is no indication the subject device would have contributed to the reported abnormal cobalt levels.

Event Description

Pursuant to dr.(redacted) correspondence, several years ago he successfully had a stryker hip implant placed in his left leg.After approximately one and half years, he began to present signs of loss of balance.Later, he stated that he began to present various more severe symptoms of the following: open lesions on his legs & thorax, lungs began to deteriorate, recurring bouts of pneumonia, epiglottis began to fail to close properly and allowing food & liquid to get into his lungs, permanent feeding tube and tracheotomy was placed in, and he now relies on a breathing machine at night, and he takes several medications.He has since learned that the type of implant that was used on him was defective.He alleges that the implant was made in part from cobalt metal, and was made in such a way that the cobalt from the implant was gradually poisoning dr.(redacted) body.Dr.(redacted) original implant has been removed, and a new one has been implanted.Dr.(redacted) states that he recently developed severe arthritis.Dr.(redacted) states that his cobalt levels before his replacement surgery were measured at 12.8, and six months after the defected implant was removed they have dropped down to just under 1.0.Dr.(redacted) takes issue with the fact that stryker failed to inform the recipients of these devices long after they knew about their potential problems.

• Brand Name: ACCOLADE TMZF HIP STEM #4
• 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: 4506670
• MDR Text Key: 5494783
• Report Number: 0002249697-2015-00288
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K994366
• 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: 09/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2012
• Device Catalogue Number: 6020-0435
• Device Lot Number: 21528903
• Other Device ID Number: STERILE LOT 0702D1RZ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2007
• 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): Required Intervention