MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CER BIOLOXD MOD HD 28MM +3 NK; PROSTHESIS, HIP

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/09/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: item #: unknown, unknown head, lot #: unknown.Item #: unknown, unknown liner, lot #: unknown.Item #: unknown, unknown cup, lot #: unknown.Ep-200146, act artic e1 hip brg 28x40mm, 247830.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.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: 0001825034-2019-03906 bearing.

Event Description

It was reported that the patient underwent initial hip replacement.Subsequently, the patient underwent revision for infection a few weeks later.During the surgery to treat the infection, the hip was dislocated and the bearing became disassembled from the head.Attempts were made to obtain additional information; however, none was available.

• Brand Name: CER BIOLOXD MOD HD 28MM +3 NK
• 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: 8958271
• MDR Text Key: 158961336
• Report Number: 0001825034-2019-03907
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051411
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 12-115111
• Device Lot Number: 2958463
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2019
• 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 Age: 55 YR