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

Catalog Number UNK_JR

Device Problems Loss of Osseointegration (2408); Insufficient Information (3190)

Patient Problems Injury (2348); Osteolysis (2377); Inadequate Osseointegration (2646)

Event Date 03/22/2018

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.

Event Description

Surgeon contacted clinical indicating he will be revising the acetabulum for a previous study patient.Indication for revision is unknown.

Event Description

Surgeon contacted clinical indicating he will be revising the acetabulum for a previous study patient.Indication for revision is unknown.Update as per surgeon: patient was revised for a loose shell due to possible osteolysis.Shell and liner were revised.

Manufacturer Narrative

Outcomes attributed to ae; executive summary; date of explant; type of reportable event.An event regarding loosening involving a shell was reported.The event was confirmed by medical review.Product evaluation and results: not performed as the device was not returned.A review of the provided medical records by a clinical consultant concluded: a review of the provided medical records and x-rays by a clinical consultant indicated: "review of these records confirms the acetabular component of a left tha implanted in 1988 was revised in 2018 secondary to acetabular loosening related to polyethylene insert wear and osteolysis.The root cause of the cannot be determined as insufficient information was available." a review of the device history records could not be performed as no lot information was provided.A complaint history review could not be performed as no lot information was provided.The investigation confirmed the event of acetabular loosening however, the root cause cannot be determined.Further information is needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: UNKNOWN OSTEONICS ACETABULAR SHELL
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7450628
• MDR Text Key: 106304420
• Report Number: 0002249697-2018-01201
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 08/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_JR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 49 YR
• Patient Weight: 52