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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Blood Loss (2597)

Event Date 04/30/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Femoral stem beaded fullcoat 12/14 neck taper std.Body std.Offset size 16 16 mm distal dia.160 mm length.Concomitant medical products: item# 00630505036 liner standard 3.5 mm offset 36 mm i.D.For use with 50/52/54 mm o.D.Shells lot# 63721280, item# 00620005420 shell porous with holes 54 mm o.D.Lot# 61215875, item# 00625006525 bone scr 6.5x25 self-tap lot# 61738462, item# 00625006530 bone scr 6.5x30 self-tap lot# 61724514, item# 00877703603 biolox⮠option, head, l, 㸠36/+3.5, taper 12/14 lot# 2911123.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.Multiple mdr reports were filed for this event, please see associated reports: 0002648920 - 2019 - 00124, 0002648920 - 2019 - 00123.

Event Description

It was reported that during a revision due to infection, the patient lost 800 ml of blood intra-operatively.No additional patient consequences were reported.Antibiotic spacers were placed.Attempts were made to obtain additional information; however, none was available.

Manufacturer Narrative

Upon review of the event, it has been determined that this event was a result of a coinciding procedure, and will be reported under medwatch 0001822565-2019-00768.The initial report was forwarded in error and should be voided.

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: 8351356
• MDR Text Key: 136529009
• Report Number: 0001822565-2019-00772
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K953337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 03/14/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 00784301606
• Device Lot Number: 61601513
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/22/2019
• Initial Date FDA Received: 02/19/2019
• Supplement Dates Manufacturer Received: 03/12/2019
• Supplement Dates FDA Received: 03/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other