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

Catalog Number 6021-0435

Device Problems Metal Shedding Debris (1804); Insufficient Information (3190)

Patient Problems Toxicity (2333); Reaction (2414)

Event Date 11/20/2014

Event Type  Injury  

Event Description

Letter received from pryers soliciotors llp advising that they are acting on behalf of a patient who wishes to initiate a product liability claim against stryker in relation to the alleged premature failure of a metal on polythene hip.The solicitor has advised that the patient has allegedly suffered from an adverse reaction to metal debris.The solicitor has reported that the patient was fitted with a stryker accolade polyethylene liner, a stryker lfit v40 femoral head and an accoldade tmzf stem.No further information has been received.

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.Device not returned to manufacturer.

Manufacturer Narrative

Please disregard the mfr report # 0002249697-2014-04750 please note that this event is duplicate of stryker report mfr.Report # 9616680-2012-00411.

Event Description

Letter received from (b)(6) advising that they are acting on behalf of a patient who wishes to initiate a product liability claim against stryker in relation to the alleged premature failure of a metal on polythene hip.The solicitor has advised that the patient has allegedly suffered from an adverse reaction to metal debris.The solicitor has reported that the patient was fitted with a stryker accolade polyethylene liner, a stryker lfit v40 femoral head and an accolade tmzf stem.No further information has been received.

Manufacturer Narrative

This legal case is a continuation of an event previously reported under 9616680-2012-00411.Reported event: an event regarding abnormal ion levels involving a v40 cocr lfit head 44mm/-4 was reported.The event was not confirmed.Method & results: -device evaluation and results: not performed as the device was not returned.-medical records received and evaluation: insufficient medical records were received for review with a clinical consultant.-device history review: a device history review confirmed all devices accepted into finished goods conformed to specification.-complaint history review: no other events were reported for the lot indicated.Conclusions: the exact cause of the event could not be determined because insufficient medical records were received for review with a clinical consultant.Further information such as patient information, operative report, need operative reports, serial x-rays, examination of explanted components and past medical history are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and/or additional information become available, this investigation will be reopened.

Event Description

Letter received from (b)(6) advising that they are acting on behalf of a patient who wishes to initiate a product liability claim against stryker in relation to the alleged premature failure of a metal on polythene hip.The solicitor has advised that the patient has allegedly suffered from an adverse reaction to metal debris.The solicitor has reported that the patient was fitted with a stryker accolade polyethylene liner, a stryker lfit v40 femoral head and an accoldade tmzf stem.No further information has been received.

• 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: sandra spokane ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4343376
• MDR Text Key: 5203988
• Report Number: 0002249697-2014-04750
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K994366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2013
• Device Catalogue Number: 6021-0435
• Device Lot Number: 25563605
• Other Device ID Number: STERILE LOT 0802WM1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2008
• 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: 80 YR