MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN - RESTORATION MODULAR HIP STEM; HIP IMPLANT

Model Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problems Inflammation (1932); Reaction (2414)

Event Date 04/03/2015

Event Type  Injury  

Manufacturer Narrative

Reported event: an event regarding elevated ion levels involving an unknown stem was reported.The event was not confirmed.Method & results: product evaluation and results: visual, dimensional, functional inspection, and material analysis were not performed as the item was not returned.Clinician review: not performed because no medical records or x-rays were made available for evaluation.Product history review: a complaint history review could not be performed as the device was not properly identified.Complaint history review: a complaint history review could not be performed as the device was not properly identified.Conclusions: the event could not be confirmed, nor the root cause determined because the devices were not returned for evaluation and insufficient medical information was provided.Further information such as medical documentation and the return of the devices are needed.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.Corrective action/preventive action: no action is required at this time as there is no indication to suggest a product non-conformity or unanticipated hazard.Product not returned.

Event Description

It was reported through the filing of a lawsuit that allegedly the patient had another lfit anatomic cocr v40 femoral head implanted on her left hip on (b)(6) 2015.It is further alleged that she suffered injuries as a result of implantation of the device at issue, device recall and excessive levels of cobalt and chromium in her blood.Patient has not yet scheduled a surgery for explantation of the femoral head at issue.

• Brand Name: UNKNOWN - RESTORATION MODULAR HIP STEM
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: anna ryan ; raheen business park; limerick NA ; 61498200
• MDR Report Key: 7964720
• MDR Text Key: 123679907
• Report Number: 0002249697-2018-03318
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNK_JR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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