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

Catalog Number UNK_REC

Device Problems Mechanical Problem (1384); Loss of Osseointegration (2408); Osseointegration Problem (3003); Insufficient Information (3190)

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

Event Date 06/20/2016

Event Type  Injury  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device 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.

Event Description

The patient was reported to have had pain so the plan was to revise the cemented stem.

Manufacturer Narrative

An event regarding loosening involving an unknown stem was reported.The event was confirmed by medical review.Method & results: device evaluation and results: not performed as product was not returned medical records received and evaluation: medical review of the x-rays provided indicated the diagnosis as stem loosening requiring revision in 2016 as end of practical service life condition caused by an adverse mix of procedure-related factors regarding limits of current device technology and patient-related factors regarding implantation conditions for malignant bone tumor during childhood.Device history review: not performed as lot information was not provided.Complaint history review: not performed as lot information was not provided.Conclusions: medical review of the x-rays provided indicated the diagnosis as stem loosening requiring revision in 2016 as end of practical service life condition caused by an adverse mix of procedure-related factors regarding limits of current device technology and patient-related factors regarding implantation conditions for malignant bone tumor during childhood.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

The patient was reported to have had pain so the plan was to revise the cemented stem.

• Brand Name: UNKNOWN CEMENTED STEM
• Type of Device: HIP 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 colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5799810
• MDR Text Key: 49745086
• Report Number: 0002249697-2016-02355
• Device Sequence Number: 1
• Product Code: KXA
• 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,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2016
• 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?: Yes
• Date Manufacturer Received: 09/30/2016
• 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): Required Intervention
• Patient Age: 37 YR