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

Catalog Number 6021-0435

Device Problems Corroded (1131); Metal Shedding Debris (1804)

Patient Problems Host-Tissue Reaction (1297); Inflammation (1932); Toxicity (2333); Test Result (2695)

Event Date 09/10/2014

Event Type  Injury  

Event Description

Pt came into theatre with hip pain.Pt had accolade tmzf and trident cup implanted approx 8 years ago.When surgeon opened up the pt he had very inflamed tissue.Dr took v40 head off stem & there was black tar like substance on the trunnion.Dr believes this is trunnionosis.Also the poly was yellow.Dr replaced liner and head with x3 liner and new lfit v40 femoral head.

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Additional information was requested and if it becomes available, the evaluation summary will be submitted in a supplemental report.

Manufacturer Narrative

An event regarding corrosion involving an accolade stem was reported.The event ¿tar-like¿ substance was confirmed through a provided photo, however, corrosion could not be confirmed.Method and results: device evaluation and results: a photo of the device shows the tar-like substance.Without return and evaluation of the device, corrosion cannot be confirmed.Medical records received and evaluation: a review indicated the substance noted is likely blood concentration but this cannot be confirmed without the devices.Records were reviewed by a consulting clinician concluding: 'screw removal required removal of both liner and femoral head and all visual aspects of the of tar-like black band near the trunnion point to most probably blood concentration as the nature of the discoloration as caused by location between femoral head inside taper and stem neck where blood resorption is impossible.Only explant materials analysis could prove such although the context of the revision case has no information to suggest that any significant taper corrosion has played any role in the failure scenario.[.] this pi case is not device-related.' device history review: the reported device was manufactured and accepted into final stock with no discrepancies.Complaint history review: there have been no other events for the reported lot id.Conclusions: the exact cause of the event could not be determined because the devices are needed to investigate for corrosion.

Event Description

Pt came into theatre with hip pain.Pt had accoalde tmzf and trident cup implanted approx 8 years ago.When surgeon opened up the pt he had very inflamed tissue.Dr took v40 head off stem and there was black tar like substance on the trunnion.Dr believes this is trunnionosis.Also the poly was yellow.Dr replaced liner and head with x3 liner and new lfit v40 femoral head.

• Brand Name: ACCOLADE PLUS 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: 4140320
• MDR Text Key: 20012682
• Report Number: 0002249697-2014-03747
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K994366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2010
• Device Catalogue Number: 6021-0435
• Device Lot Number: 15222404
• Other Device ID Number: STERILE LOT 0510E1RZ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2005
• 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
• Patient Age: 70 YR