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

Model Number N/A

Device Problem Device Packaging Compromised (2916)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/03/2018

Event Type  malfunction  

Manufacturer Narrative

(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 the device was opened from its outer packaging with no reported issues.The device in its inner sterile packaging was then given to the surgical nurse to open in the sterile field.When the technician received the device in its inner sterile packaging from the nurse, the malfunction was noted.The technician opened the outer sterile cavity to remove the inner sterile cavity.The femoral stem was noted to have protruded thru the inner sterile cavity.The surgeon rejected the device due to possible contamination.An alternate device was used, and there is no reported impact to the patient.Attempts have been made, and no further information has been provided.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.Evaluation of the returned product confirmed that at the distal end of the stem the inner cavity was punctured and the outer cavity showed signs of stress.Dhr was reviewed and no discrepancies relevant to the reported event were found.Transit damage is considered to be the root cause of the reported issue.This event has been elevated to a capa for further investigation.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

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

• Brand Name: FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7601074
• MDR Text Key: 111058530
• Report Number: 0001822565-2018-03263
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: PK032726
• 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: 04/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 00771101720
• Device Lot Number: 62478944
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/21/2018
• Initial Date FDA Received: 06/14/2018
• Supplement Dates Manufacturer Received: 04/23/2019
• Supplement Dates FDA Received: 04/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR