MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CER BIOLOXD OPTION HD 44MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Thrombosis (2100)

Event Date 06/05/2013

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: arcos con sz c hi 70mm, pn 11-301333, ln 965090.Arcos 17x190mm spl tpr dist, pn 11-300917, 1ln 21310.Cer option type 1 tpr sleve -6, pn 650-1064, ln: unk.Multiple mdr reports were filed for this event.Please see reports: 0001825034-2018-06462, 0001825034-2018-06463, 0001825034-2018-06466.Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies were found.It is unknown whether the components were implanted with the correct fit and orientation per the surgical technique.Root cause could not be determined with information available.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.Product remains implanted.

Event Description

It was reported patient was noted to have deep vein thrombosis post implantation.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: CER BIOLOXD OPTION HD 44MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7999520
• MDR Text Key: 124823137
• Report Number: 0001825034-2018-09907
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093549
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/24/2018

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 650-1059
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/01/2018
• Initial Date FDA Received: 10/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 94