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U.S. Department of Health and Human Services

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

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STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE TMZF HIP STEM HIP IMPLANT Back to Search Results
Catalog Number UNK_SHC
Device Problems Degraded (1153); Material Deformation (2976); Naturally Worn (2988)
Patient Problems Inflammation (1932); Necrosis Of Flap Tissue (1972); Tissue Damage (2104); Weakness (2145); Discomfort (2330); Injury (2348); Reaction (2414)
Event Date 10/21/2016
Event Type  Injury  
Event Description
It was reported by the patient's attorney through the filing of a lawsuit that the patient underwent a left hip total arthroplasty on (b)(6) 2006. It is further alleged that after implantation the patient "began experiencing popping, catching, weakness and discomfort on his left side. Diagnostic workup revealed metallosis and marked elevation of serum cobalt and chromium". The patient's left hip was revised on (b)(6) 2016. Dr. (b)(6) noted that the capsule was filled with cloudy fluid, considerable black material around the entire aspect of the joint down to the femur. He also noted the existence of local tissue reaction and necrosis of the tissue. The trunnion has been worn down to a fine point, making the neck unstable, causing damage to the plastic and surrounding tissue.
 
Manufacturer Narrative
This report was found to be a duplicate of a previously reported event under mfr report # 0002249697-2016-03646. Investigation findings will be provided in a supplemental report under mfr report # 0002249697-2016-03646 and any additional reports will be generated if needed.
 
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. Kept by the attorney.
 
Event Description
It was reported by the patient's attorney through the filing of a lawsuit that the patient underwent a left hip total arthroplasty on (b)(6) 2006. It is further alleged that after implantation the patient "began experiencing popping, catching, weakness and discomfort on his left side. Diagnostic workup revealed metallosis and marked elevation of serum cobalt and chromium". The patient's left hip was revised on (b)(6) 2016. Dr. (b)(6) noted that the capsule was filled with cloudy fluid, considerable black material around the entire aspect of the joint down to the femur. He also noted the existence of local tissue reaction and necrosis of the tissue. The trunnion has been worn down to a fine point, making the neck unstable, causing damage to the plastic and surrounding tissue.
 
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Brand NameACCOLADE TMZF HIP STEM
Type of DeviceHIP IMPLANT
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
MDR Report Key7238317
MDR Text Key284104971
Report Number0002249697-2018-00309
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup
Report Date 02/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK_SHC
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/16/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 02/02/2018 Patient Sequence Number: 1
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