MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SEE H10 NARRATIVE; PROSTHESIS, HIP

Model Number N/A

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Code Available (3191)

Event Date 05/16/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Femoral stem 12/14 neck taper plasma sprayed press-fit cementless size 4 extended offset reduced neck length.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 the implant outer box was opened after surgeon prepared femur, and the inner box was contaminated from the stem protruding out.Attempts were made to obtain additional information; however, none was available.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.Device history record (dhr) was reviewed and no discrepancies were found.Investigation results concluded that the reported event was due to transit damage.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: SEE H10 NARRATIVE
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8782785
• MDR Text Key: 150830445
• Report Number: 0001822565-2019-02907
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 10/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 00771100440
• Device Lot Number: 62243349
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1