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

Model Number N/A

Device Problem Mechanical Jam (2983)

Patient Problems Blood Loss (2597); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Modular femoral stem press-fit plasma sprayed cementless size 7.5.Concomitant medical products: item# 00784802201 modular neck taper lot# 63609968, item# unknown unknown cup lot# unknown, item# unknown unknown liner lot# unknown, item# unknown unknown head lot# unknown.Foreign source: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2019 - 02307.

Event Description

It was reported that a patient had hip implant surgery.Patient underwent revision on an unknown date.During the revision surgery the neck component did not readily come off from the stem component.This caused the surgery to be extended by 60 minutes.The patient also had blood loss.Additional information was requested, however none was available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.The modular neck was returned and visual examination identified severe damage, including gouges and burnishing.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.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: SEE H10 NARRATIVE
• Type of Device: PROSTHESIS HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8677181
• MDR Text Key: 147292199
• Report Number: 0001822565-2019-02358
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• PMA/PMN Number: K063251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/22/2019

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00771300700
• Device Lot Number: 63607154
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/10/2019
• Initial Date FDA Received: 06/06/2019
• Supplement Dates Manufacturer Received: 10/18/2019
• Supplement Dates FDA Received: 10/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other