MAUDE Adverse Event Report: BIOMET ORTHOPEDICS STAGEONE SELECT CEMENT SPACER MOLDS FOR TEMPORARY HIP REPLACEMENT; PROSTHESIS, HIP

Catalog Number 431193

Device Problem Device Packaging Compromised (2916)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/20/2017

Event Type  malfunction  

Manufacturer Narrative

Cmp-(b)(4).(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that after opening inner carton packaging was compromised.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The complaint sample was evaluated, and the reported event was confirmed.Visual inspection of returned product determined that the outer tyvek lid shows evidence that a seal existed along the entire perimeter of the outer tyvek cavity.Review of the inner cavity shows that the corner of the tyvek lid has begun to peal off of the blister cavity.The corner that is peeled back show evidence that a seal existed between the tyvek lid and the blister cavity.Device history record (dhr) was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required.The root cause of the reported event is a manufacturing deficiency as the breach in the seal was likely caused by either the foam pushing on the seal and forcing it open or by the inner seal being breached when the outer seal was opened.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: STAGEONE SELECT CEMENT SPACER MOLDS FOR TEMPORARY HIP REPLACEMENT
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6513389
• MDR Text Key: 73415316
• Report Number: 0001825034-2017-02730
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK080979
• 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
• Report Date: 08/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/20/2020
• Device Catalogue Number: 431193
• Device Lot Number: 770990
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2015
• 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