MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH DEDICACE. V40(TM) FEMORAL STEM; HIP IMPLANT

Catalog Number 4900-1-111

Device Problems Dent in Material (2526); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/10/2015

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.The subject device is not cleared for sale in the u.S., but a similar device is commercially available in the u.S.

Event Description

The pharmacist at the hospital returned the device to stryker (b)(4) without any mention.After a phone call to the contact person, she reported that "the stem was returned because it had like an impact on it.The surgeon did not want to use it.Another stem was available for complete the procedure without delay or adverse consequences.".

Manufacturer Narrative

An event regarding damage involving a dedicace stem was reported.The event was not confirmed.Method & results: device evaluation and results: visual inspection for the stem noted residue at the distal end of the stem.There was no evidence of damage or an 'impact' to the device.Material analysis report concluded that: the indication observed was a white residue with evidence of both poly(methyl-methacrylate) and zirconium.Both of which are known ingredients in bone cement used for fixation of a prosthesis to living bone in orthopaedic.Medical records received and evaluation: not performed as no medical records were provided.Device history review: the device was manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: the exact cause of the event could not be determined based on the information provided.In the event it is stated that there was an 'impact' noted on the device.The was no evidence of damage on the returned device, however a reside was noted on the distal end of the stem.Material analysis concluded that: the indication observed was a white residue with evidence of both poly(methyl-methacrylate) and zirconium.Both of which are known ingredients in bone cement used for fixation of a prosthesis to living bone in orthopaedic.The dedicace stem is indicated for cemented hip applications.The supplier of the stem confirmed that there is no bone cement or similar products used in lmo.No further investigation is possible at this time.If additional information becomes available, this investigation will be reopened.

Event Description

The pharmacist at the hospital returned the device to stryker (b)(4) without any mention.After a phone call to the contact person, she reported that "the stem was returned because it had like an impact on it.The surgeon did not want to use it.Another stem was available for complete the procedure without delay or adverse consequences.".

• Brand Name: DEDICACE. V40(TM) FEMORAL 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: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5358275
• MDR Text Key: 35971446
• Report Number: 0002249697-2016-00037
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 12/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: 4900-1-111
• Device Lot Number: G5671512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2015
• 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