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

Catalog Number 4900-1-133

Device Problems Particulates (1451); Device Packaging Compromised (2916)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/10/2015

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 or manager at the hospital reported that when opening the device, a particle in the blister was found.No consequences occurred.

Manufacturer Narrative

An event regarding foreign matter involving a dedicace stem was reported.The event was confirmed.Method & results: device evaluation and results: the stem was returned sealed within the packaging.Particles were observed in the packaging.A material analysis report concluded: particles in the packaging of dedicace v40 femoral stem were confirmed to be observed.The particles consisted of white and brown material located in different areas of the inner blister packaging.Ftir analysis of the brown particle was found to give a ftir spectrum consistent with that of polyester.Ftir analysis of the white particle was found to give ftir spectrum consistent with that expected of polypropylene olefin material 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 device was returned to (b)(4) for review and the particles confirmed as present in the sealed packaging.Ncr was raised in (b)(4) to investigate the event.In conclusion particles observed in the packaging of dedicace v40 femoral stem were confirmed to be observed.The particles consisted of white and brown material located in different areas of the inner blister packaging.Ftir analysis of the brown particle was found to give a ftir spectrum consistent with that of polyester.Ftir analysis of the white particle was found to give ftir spectrum consistent with that expected of polypropylene olefin material.

Event Description

The (b)(6) at the hospital reported that when opening the device, a particle in the blister was found.No consequences occurred.

• 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: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5233214
• MDR Text Key: 31711439
• Report Number: 0002249697-2015-03866
• Device Sequence Number: 1
• Product Code: KWA
• 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: Nursing Assistant
• Type of Report: Initial,Followup
• Report Date: 10/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4900-1-133
• Device Lot Number: G5701107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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