MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ANATO STEM SZ 6 RIGHT NEUT; IMPLANT

Catalog Number 4845-7-116

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

Patient Problem No Code Available (3191)

Event Date 02/19/2015

Event Type  Injury  

Event Description

Dr mentioned that the stem he implanted was undersized.Implanted a bigger stem and changed the head.Implanted 8rt neutral and 36 -5 biolox head.

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available, the evaluation summary will be submitted in a supplemental report.Hospital policy.

Manufacturer Narrative

Device history review: review of the device history records indicate devices were manufactured and accepted into final stock.Complaint history review: there have been no other events reported for the reported manufacturing lot.Patient details were reviewed and no indication was found that the event was related to device design, materials, or manufacturing.Clinician review of the provided information determined, "there is no progressive radiographic subsidence noted and start-up pain at two months post-surgery in a large male patient may represent remodeling discomfort and/or delayed biologic fixation.There is no progressive radiographic subsidence noted and start-up pain at two months post-surgery in a large male patient may represent remodeling discomfort and/or delayed biologic fixation." there is no indication at this time that the design, materials, or manufacturing of the subject device contributed to the event.If additional information becomes available, this investigation will be reopened.

Event Description

Dr mentioned that the stem he implanted was undersized.Implanted a bigger stem and changed the head.Implanted 8rt neutral and 36 -5 biolox head.

Manufacturer Narrative

An event regarding implantation of an undersized stem involving an anato stem was reported.The event was confirmed.Method and results: device evaluation and results: not performed as no items were returned.Medical records received and evaluation: the provided medical information was reviewed by a consulting clinician who concluded: the fact that a larger femoral component was easily inserted suggests the possibility of under-sizing the primary stem.There is no evidence that factors of faulty component design, manufacturing, or materials were responsible for this clinical situation.¿ device history review: review of the device history records indicates that all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for this lot.Conclusions: a review of the revision operative report described the position of the stem as ¿fibrous fixation with micromotion.¿ the root cause was determined to be use error.The surgeon implanted an undersized component.There is no indication at this time that the event is device-related.If additional information or devices become available, this investigation will be reopened.

Event Description

Dr mentioned that the stem he implanted was undersized.Implanted a bigger stem and changed the head.Implanted 8rt neutral and 36 -5 biolox head.

• Brand Name: ANATO STEM SZ 6 RIGHT NEUT
• 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: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4611167
• MDR Text Key: 20069309
• Report Number: 0002249697-2015-00773
• 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,health professional,oth
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: 4845-7-116
• Device Lot Number: 46358101
• Other Device ID Number: STERILE LOT 1404CLM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2014
• 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): Required Intervention
• Patient Age: 50 YR
• Patient Weight: 108