MAUDE Adverse Event Report: ZIMMER, INC. SEGMENTAL SYSTEM STEM EXTENSION

Catalog Number 00585207412

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/04/2015

Event Type  malfunction  

Event Description

It was reported that during surgery, it was discovered that the implant pierced the packaging; the sterility of the implant was compromised.The surgeon opened another implant to finish the procedure.

Manufacturer Narrative

This report will be amended when our investigation is complete.

Manufacturer Narrative

This report will be amended when our investigation is complete.

Manufacturer Narrative

Visual inspection of the package confirms that the stem is protruding from the inner sterile package and the outer box.The outer edge of the box appears to be crushed as a result of possible dropping during transportation.Review of the device history records did not find any deviations or anomalies.This device is used for treatment.Packaging department of zimmer was notified.The packaging of all the devices is verified before leaving zimmer facility and the event is likely to have occurred outside of the zimmer facility control.A product history search revealed no additional complaints against the related part and lot combinations.It is likely that the device was dropped or handled roughly during transit.However, the complaint may be revised upon return of product or further information.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: the complaint was evaluated and the reported event was confirmed.Visual examination confirms that the stem is protruding from the inner sterile package and the outer box.The outer edge of the box appears to be crushed as a result of possible dropping during transportation.The condition exhibited is consistent with transit damage.Dhr was reviewed and no discrepancies were found.The root cause of the product damage appears to be transit.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: SEGMENTAL SYSTEM STEM EXTENSION
• Manufacturer (Section D): ZIMMER, INC.; p.o. box 708; warsaw IN 46581 0708
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582-0708 ; 5745273773
• MDR Report Key: 4901407
• MDR Text Key: 6072817
• Report Number: 1822565-2015-01135
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: PK081860
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor,distributor,foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: 00585207412
• Device Lot Number: 62133612
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/09/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2012
• 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