MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_RECONSTRUCTIVE_PRODUCT; IMPLANT

Catalog Number UNK_REC

Device Problems Mechanical Problem (1384); Migration or Expulsion of Device (1395); Unintended Movement (3026); Insufficient Information (3190)

Patient Problems Pain (1994); Injury (2348)

Event Date 10/02/2014

Event Type  Injury  

Event Description

Patient has resorption medially and laterally with slight subsidence.She has some pain and stiffness.

Manufacturer Narrative

Catalogue number unknown at this time.Device description reported as an unknown triathlon tritanium tibial component.An evaluation of the device cannot be performed as the device remained implanted in the patient and was not returned to the manufacturer.Additional information has been requested.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Not returned to the manufacturer.

Manufacturer Narrative

A review of the provided x-rays by a clinical consultant indicated: "based on current findings it is not possible to establish a firm root cause of failure for this case with a tritanium baseplate fixation problem although there is no evidence for a device-related problem." the event was confirmed.The exact root cause could not be determined because insufficient medical information was provided.Operative reports, progress notes, and clinical history are needed.If additional information is received, this investigation will be reopened and re-evaluated.

Event Description

Patient has resorption medially and laterally with slight subsidence.She has some pain and stiffness.

Manufacturer Narrative

The patient is (b)(6) in height.An event regarding a patient with resorption, slight subsidence, pain, and stiffness involving an unknown tritanium baseplate was reported.The event was not confirmed.Method and results: device evaluation and results: could not be performed as no items associated with the event were returned or made available for identification or evaluation.Medical records received and evaluation: the provided x-ray was submitted to a consulting clinician who deemed it insufficient for a medical review.Device history review: a review of the device history records could not be performed as no lot information was provided.Complaint history review: a complaint history review could not be performed as no lot information was provided.Conclusions: the event could not be confirmed nor the root cause determined because the devices were not returned for evaluation and no medical information was provided.

Event Description

Patient has resorption medially and laterally with slight subsidence.She has some pain and stiffness.

• Brand Name: UNKNOWN_RECONSTRUCTIVE_PRODUCT
• Type of Device: 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: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4208316
• MDR Text Key: 4966757
• Report Number: 0002249697-2014-04027
• 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: Other,Health Professional,health professional,oth
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_REC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/03/2015
• 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
• Patient Age: 62 YR
• Patient Weight: 89