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

Catalog Number 4900-1-132

Device Problems Contamination (1120); Difficult to Open or Remove Packaging Material (2922); Packaging Problem (3007)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 10/26/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The risk manager, related that "the label was hard to remove.We wanted to open it to take the implant in the 2nd package.The implant fell on the floor, it is not broken, but the protection ring broke.It is impossible to use the direction element.We used another implant ref 4900-1-133".

Manufacturer Narrative

An event regarding damage packaging of a dedicate stem was reported.The event was confirmed following inspection of returned part.Device evaluation and results: the stem was returned intact in its packaging.It was noted however that the plastic protector packaging was damaged and fractured into a number of separate pieces.No damage to the stem was noted.Medical records received and evaluation: a review of medical records was not performed as none were provided.No further information was requested as there is no indication that the event was related to patient factors.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.Conclusions: a investigation carried out by the supplier concluded " no action is required at this time as there was no indication of a manufacturing issue.Lmo qa product surveillance will continue to monitor for trends".The root cause of the event could not be determined.No further investigation for this event is possible at this time if additional information become available, this investigation will be reopened.

Event Description

The risk manager, related that "the label was hard to remove.We wanted to open it to take the implant in the 2nd package.The implant fell on the floor, it is not broken, but the protection ring broke.It is impossible to use the direction element.We used another implant ref 4900-1-133.".

• 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: brian lauro ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6118290
• MDR Text Key: 60876647
• Report Number: 0002249697-2016-03713
• Device Sequence Number: 1
• Product Code: LPH
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 10/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/22/2020
• Device Catalogue Number: 4900-1-132
• Device Lot Number: G5674598
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/27/2016
• Initial Date FDA Received: 11/21/2016
• Supplement Dates Manufacturer Received: 09/22/2017
• Supplement Dates FDA Received: 10/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2015
• 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