MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MERIDIAN TMZF HIP STEM #3/13MM; HIP IMPLANT

Catalog Number 6265-1-007

Device Problems Degraded (1153); Insufficient Information (3190)

Patient Problems Inflammation (1932); Injury (2348); Reaction (2414); Insufficient Information (4580)

Event Date 02/28/2019

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.Device evaluated by manufacturer? not returned.

Event Description

It was reported through the filing of a lawsuit that allegedly the patient was implanted with and lfit anatomic cocr v40 femoral head on her right hip on or about (b)(6) 2007 and was revised on (b)(6) 2019.It is further alleged that she suffered injuries as a result of implantation and explantation of the device at issue and excessive levels of chromium and cobalt in her blood.

Manufacturer Narrative

Reported event: an event regarding abnormal ion level involving a meridian stem was reported.The event was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Product history review: not performed as the device lot details were not provided.Complaint history review: not performed as the device lot details were not provided.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as device lot detail, return of the device, pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.It was reported that the customer was inquiring if the reported device is subject to a recall.However, as the provided device identification was invalid, it cannot confirm whether the reported device is subject to a recall.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

Event Description

It was reported through the filing of a lawsuit that allegedly the patient was implanted with and lfit anatomic cocr v40 femoral head on her right hip on or about (b)(6) 2007 and was revised on (b)(6) 2019.It is further alleged that she suffered injuries as a result of implantation and explantation of the device at issue and excessive levels of chromium and cobalt in her blood.

• Brand Name: MERIDIAN TMZF HIP STEM #3/13MM
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8752757
• MDR Text Key: 149780770
• Report Number: 0002249697-2019-02478
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• PMA/PMN Number: K972228
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 09/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 6265-1-007
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention