MAUDE Adverse Event Report: ZIMMER, INC. FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED PRESS-FIT CEMENTLESS SIZE 5; HIP, PROSTHESIS

Model Number N/A

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/01/2016

Event Type  malfunction  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.

Event Description

It was reported that upon opening implant box, it was noticed that the implant had perforated the double plastic wrapping.Another implant was opened.No harm to patient.No debris found.Surgery was not delayed.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: correction: complaint sample was evaluated and the reported event was confirmed.The femoral stem packaging was returned and from the returned package evaluation determined that, the inner and outer cavities were cracked on the cavity flange, outer cavity was damaged and the outer carton box shows the transit damage.Device history record was reviewed and no discrepancies were found.The cracked cavities damage can be caused due to the outside forces during transit or the forces due to the implant.As it's unknown how many times it has been in shipping and it was in the field for a long time, the root cause for the reported issue is attributed to be transit damage.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: FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED PRESS-FIT CEMENTLESS SIZE 5
• Type of Device: HIP, PROSTHESIS
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6143761
• MDR Text Key: 61699765
• Report Number: 0001822565-2016-04520
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PK032726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 00771100520
• Device Lot Number: 60917333
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1