MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LINER AND SHELL WITH PLASTIC BARRIER 40 MM I.D. 50 MM O.D.; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Blood Loss (2597)

Event Date 01/29/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: foreign country: (b)(6).Device evaluated by mfr: the device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event; please see associated reports: 0001822565-2019-01083.

Event Description

It was reported patient experienced a loss of 1200 cc of blood intraoperatively.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.Reported event was confirmed with clinical notes.Review of the device history record identified no deviations or anomalies that would contribute to reported event.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: LINER AND SHELL WITH PLASTIC BARRIER 40 MM I.D. 50 MM O.D.
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8416807
• MDR Text Key: 138669174
• Report Number: 0001822565-2019-01082
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• PMA/PMN Number: EXPORT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Type of Report: Initial,Followup
• Report Date: 06/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 00151505040
• Device Lot Number: 61864755
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: ZIMMER HEAD, CATALOG# 00877504002, LOT# 2596960; ZIMMER STEM, CATALOG# 00771101200, LOT# 62483278; ZIMMER HEAD, CATALOG# 00877504002, LOT# 2596960; ZIMMER STEM, CATALOG# 00771101200, LOT# 62483278
• Patient Outcome(s): Other
• Patient Age: 43 YR
• Patient Weight: 89