MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ANATO STEM SZ 5 RIGHT ANTEVERT; IMPLANT

Catalog Number 4845-7-105

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/01/2014

Event Type  Injury  

Event Description

The surgeon was performing right anterior hip using the anato hip stem.He broached to a size five right.He decided that for this patient it was the correct size.The implant was opened by the nurse.It was then implanted.The stem seated slightly lower than he expected.He decide the bone was soft due to the patient's age to remove it and go to a larger size.He removed the stem with the extractor and broached to a size 6 which he was satisfied with the seated position.The case finished without an incident.

Manufacturer Narrative

Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.Not returned.

Manufacturer Narrative

An event regarding seating height discrepancy involving an anato stem was reported.The event was not confirmed.Device evaluation could not be performed as no items were returned.Medical records received and evaluation indicated that insufficient medical records were received for review with a clinical consultant.Device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.Complaint history review found no other similar events have been reported for the subject manufacturing lot.The event could not be confirmed nor the root cause of the reported seating height discrepancy determined due to the minimal information received.No further investigation for this event is possible at this time.

Event Description

The surgeon was performing right anterior hip using the anato hip stem.He broached to a size five right.He decided that for this patient it was the correct size.The implant was opened by the nurse.It was then implanted.The stem seated slightly lower than he expected.He decide the bone was soft due to the patient's age to remove it and go to a larger size.He removed the stem with the extractor and broached to a size 6 which he was satisfied with the seated position.The case finished without an incident.

• Brand Name: ANATO STEM SZ 5 RIGHT ANTEVERT
• Type of Device: 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: niku kasmai ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3941299
• MDR Text Key: 4576206
• Report Number: 0002249697-2014-02779
• Device Sequence Number: 1
• Product Code: MAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123604
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: 4845-7-105
• Device Lot Number: 45084107
• Other Device ID Number: STER. LOT 1401JCM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/01/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2014
• 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): Other
• Patient Age: 86 YR
• Patient Weight: 66