MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COCR INTEGRAL CENTR 15X155MM; PROSTHEIS, HIP

Model Number N/A

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

Patient Problem Blood Loss (2597)

Event Date 09/01/2011

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 11-300816, arcos 16x150mm spl tpr dist, 523080, 11-301343, arcos con sz c std 80mm, 391680, 157444, m2a-magnum mod hd sz 44mm, 006080, unknown, stryker titanium cup, unknown, unknown, 6.5 screw length 35, 35, 24 mm, unknown, unknown, stryker x3 liner, unknown.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: 0001825034 - 2018 - 01755, 0001825034 - 2018 - 01757, 0001825034 - 2018 - 01758.Remains implanted.

Event Description

It was reported that the patient experienced a blood loss of 1500cc during a stage ii revision procedure.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

The following report is submitted to relay correct and additional information received.Concomitant medical products: 139246  endo ii taper insert +3mm t1 937440.  12-139012 endo ii mod endo head sz 44 431060.  ep-108625 e-poly 44mm +3 mrom lnr sz25 008450.  the reported event is confirmed based on the surgical notes that was provided.Device history record was reviewed and identified no deviations or anomalies.Root cause was unable to 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.

• Brand Name: COCR INTEGRAL CENTR 15X155MM
• Type of Device: PROSTHEIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7336389
• MDR Text Key: 102312589
• Report Number: 0001825034-2018-01756
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• PMA/PMN Number: PK942479
• 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: 04/26/2018

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: Physician
• Device Expiration Date: 10/30/2016
• Device Model Number: N/A
• Device Catalogue Number: 12-162615
• Device Lot Number: 608770
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/15/2018
• Initial Date FDA Received: 03/13/2018
• Supplement Dates Manufacturer Received: 04/26/2018
• Supplement Dates FDA Received: 04/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 65 YR
• Patient Weight: 90