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

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  

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.

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.

• Brand Name: ACCOLADE TMZF HIP STEM
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7238317
• MDR Text Key: 98913092
• Report Number: 0002249697-2018-00309
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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 Received: 02/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SHC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention