MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH HMRS ROT H DIST FEMUR LT 100MM; IMPLANT

Catalog Number 64834210

Device Problems Migration or Expulsion of Device (1395); Device Operates Differently Than Expected (2913); Insufficient Information (3190)

Patient Problems Muscle Weakness (1967); Injury (2348)

Event Date 04/05/2017

Event Type  Injury  

Manufacturer Narrative

The event involves a device that is not cleared for sale in the u.S., but similar device is commercially available in the u.S.It was noted that the device is not available for evaluation.Additional information has been requested.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

A rotation of the femur was seen in the patient using hmrs.

Manufacturer Narrative

Reported event: an event regarding revision involving a hmrs femoral component was reported.The event was confirmed as the device was returned.Method & results: device evaluation: there are scratches and blemishes throughout the device consistent with in-vivo use and subsequent explantation damage.The device is otherwise unremarkable.Medical records received and evaluation: a review of the provided clinical images by a clinical consultant indicates that based on the limited information provided medical review indicates that the muscle atrophy after a large segmental femoral resection prior to hmrs implantation has contributed to diminished dynamic contraction forces across the taper junction between anchorage device and extension piece with gradual loss of taper lock.The external rotating vector around the hip with similar internal rotation forces in the distal femur has caused an external rotation error of the anchorage device requiring revision.Device history review: the device was manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for the lot referenced.Conclusions: based on the limited information provided medical review indicates that the muscle atrophy after a large segmental femoral resection prior to hmrs implantation has contributed to diminished dynamic contraction forces across the taper junction between anchorage device and extension piece with gradual loss of taper lock.The external rotating vector around the hip with similar internal rotation forces in the distal femur has caused an external rotation error of the anchorage device requiring revision.However further information such improved imaging, x-rays of the primary and pre-revision surgeries are required to determine a root cause.No further investigation is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

A rotation of the femur was seen in the patient using hmrs.

• Brand Name: HMRS ROT H DIST FEMUR LT 100MM
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA
• Manufacturer Contact: jadwiga degrado ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6537617
• MDR Text Key: 74204074
• Report Number: 0002249697-2017-01431
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2020
• Device Catalogue Number: 64834210
• Device Lot Number: ABK8A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/28/2015
• 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): Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 65