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

Catalog Number UNK_SHC

Device Problems Inadequacy of Device Shape and/or Size (1583); Loss of Osseointegration (2408)

Patient Problems Pain (1994); Injury (2348); Inadequate Osseointegration (2646)

Event Date 08/01/2017

Event Type  Injury  

Manufacturer Narrative

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

It was reported that the patient had right hip pain.The doctor states the stem was grossly loose.The primary hip was done through direct anterior approach.

Manufacturer Narrative

An event regarding loosening involving an unknown anato stem was reported.The event was confirmed following a review by a clinical consultant.Device evaluation and results: a visual, dimensional and functional inspection was not performed as the device was not returned for evaluation.Medical records received and evaluation: a review of the provided medical records and x-rays by a clinical consultant indicated: the stem is grossly loose with subsidence of at least 1-cm and radiolucent lines around the stem.Pedestal formation is visible around the stem tip.The stem is probably slightly undersized relative to the diameter of the femur.Lateral x-ray shows the femoral head in slight subluxation with lift-off of the head from the liner and a clear impingement condition between skirted head and liner of the x3 cup insert.The principal problem of this case is cup malposition leading to an overload condition with stem loosening.Device history review could not be performed as the device lot is unknown.Complaint history review could not be performed as the device lot is unknown.Conclusions: a review by a clinical consultant concluded: cup malposition in excessive anteversion as principal failure contributor in combination with slight undersizing of the femoral stem and use of a skirted femoral head have contributed to an impingement condition in the arthroplasty with a consequent overload condition on the stem causing anato stem loosening requiring revision within 1-year.Further information such as device details, return of device, additional operative reports, patient history & follow-up notes are needed to investigate this event further.If additional information and/or device become available, this investigation will be reopened.

Event Description

It was reported that the patient had right hip pain.The doctor states the stem was grossly loose.The primary hip was done through direct anterior approach.

• Brand Name: UNKNOWN ANATO STEM
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: brian lauro ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6827295
• MDR Text Key: 83879264
• Report Number: 0002249697-2017-02622
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SHC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2017
• 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): Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Weight: 81