MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM 12/14 NECK TAPER; PROSTHESIS, HIP

Model Number N/A

Device Problems Tear, Rip or Hole in Device Packaging (2385); Device Packaging Compromised (2916)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/14/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that when opening the implant from the box there was an open hole in the plastic container, and the stem tip was shifted towards perforation and through the foam.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

The complaint device has been returned, but the device investigation has not yet been completed.Once the evaluation is completed, a supplemental medwatch 3500a will be submitted.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.

Event Description

Further information received indicates that due to the event, the surgeon had to broach to the next size.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.The femoral stem and its packaging were returned.From the returned product evaluation it was determined that folding carton exhibits damage to the end panels, as well as a hole that protruded through the inner and outer thermal cavities.Debris was found in between cavities and this was found to be packaging material.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 the product was in transit for approximately three and half years and the outer carton showed minor damage, the cavities have a hole due to forces developed from the movement of an implant during transit.So the root cause for the reported issue is attributed to be product damaged in shipping/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.

Manufacturer Narrative

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
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7331580
• MDR Text Key: 102205751
• Report Number: 0001822565-2018-01336
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 00771100410
• Device Lot Number: 62792984
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2018
• Initial Date FDA Received: 03/12/2018
• Supplement Dates Manufacturer Received: 03/16/2018; 04/17/2018; 04/18/2018
• Supplement Dates FDA Received: 04/11/2018; 04/17/2018; 04/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2014
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 75