MAUDE Adverse Event Report: ZIMMER IN ZIMMER M/L TAPER FEMORAL STEM

Catalog Number 65771101620

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/01/2015

Event Type  malfunction  

Event Description

It is reported the implant what when the implant was removed from the box, sterilization was compromised.

Manufacturer Narrative

This report will be amended when our investigation is complete.

Manufacturer Narrative

This report is being amended to reflect changes.Visual inspection of the returned device confirmed that the external protective carton was damaged.The device was returned unused.The shrink wrap was missing.Both corners of the package exhibit damage consistent with transit damage.The external sterilized cavity seal was intact with stress marks near the flange.The internal cavity tyvek seal was intact; however, the internal sterile cavity itself was compromised with fracture at a point of contact with the stem.Plastic debris and black residue was observed on the plastic bag which houses the stem inside the packaging configuration, and at the point where the taper penetrated the sterile cavity.This device is used for treatment.This device has been in distribution for approximately 8 years and 11 months.The amount of distribution during this timeframe is unknown.Review of the complaint history for the lot code associated with the returned device indicated no prior complaints for this lot.A previous investigation for a similar issue of black residue resulted in a new packaging configuration.This new configuration has been tested to show that it maintains package integrity following environmental and distribution conditioning.This is currently being implemented, and this product will be included in that change.Based on the information provided a probable cause for the package damage is excessive shipping and handling, beyond normal anticipated distribution.

• Brand Name: ZIMMER M/L TAPER FEMORAL STEM
• Manufacturer (Section D): ZIMMER IN ; p.o. box 708; warsaw IN 46581 0708
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 4861706
• MDR Text Key: 16466580
• Report Number: 1822565-2015-00953
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor,distributor,health prof
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/19/2015

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: 05/31/2016
• Device Catalogue Number: 65771101620
• Device Lot Number: 60469301
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/19/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/19/2015
• Initial Date FDA Received: 06/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2006
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 64 YR