MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN UNKNOWN SHELL; HIP IMPLANT

Catalog Number UNK_JR

Device Problem Malposition of Device (2616)

Patient Problem Injury (2348)

Event Date 04/01/2019

Event Type  Injury  

Manufacturer Narrative

An event regarding malposition involving an unknown shell was reported.The event was confirmed by medical review.Method & results: device evaluation and results: not performed as the device was not returned.Clinician review: the available medical records were provided to a consulting clinician for a review which was rejected stating - "provided x-ray does not confirm the reported event but notes acetabular shell is vertical.Need operative reports, office/clinical reports, serial x-rays, and examination of the explanted components." device history review: not performed as the device was not identified properly.Complaint history review: not performed as the device was not identified properly.Conclusion: it was reported that the patient's hip was revised due to dislocation.The available medical records were provided to a consulting clinician for a review which was rejected stating that provided x-ray does not confirm the reported event but notes acetabular shell is vertical.Need operative reports, office/clinical reports, serial x-rays, and examination of the explanted components.The exact cause of the event could not be determined because insufficient information was provided.Additional information, including operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

Event Description

Patient hip dislocating, liner and head explanted.Reimplanted new head, liner, and screw.Update 15/may/2019: clinician review "notes acetabular shell is vertical".

Event Description

Patient hip dislocating, liner and head explanted.Reimplanted new head, liner, and screw.Update 15/may/2019: clinician review "notes acetabular shell is vertical".

Manufacturer Narrative

Additional information: explant date an event regarding malposition involving an unknown shell was reported.The event was confirmed by medical review.Method & results: - device evaluation and results: not performed as the device was not returned.- clinician review: the available medical records were provided to a consulting clinician for a review which was rejected stating - "provided x-ray does not confirm the reported event but notes acetabular shell is vertical.Need operative reports, office/clinical reports, serial x-rays, and examination of the explanted components." - device history review: not performed as the device was not identified properly.- complaint history review: not performed as the device was not identified properly.Conclusion: it was reported that the patient's hip was revised due to dislocation.The available medical records were provided to a consulting clinician for a review which was rejected stating that provided x-ray does not confirm the reported event but notes acetabular shell is vertical.Need operative reports, office/clinical reports, serial x-rays, and examination of the explanted components.The exact cause of the event could not be determined because insufficient information was provided.Additional information, including operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

• Brand Name: UNKNOWN UNKNOWN SHELL
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8616840
• MDR Text Key: 145277839
• Report Number: 0002249697-2019-01961
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 06/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_JR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 52 YR