MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CER OPTION TYPE 1 TPR SLEVE -3; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Cellulitis (1768); Thrombosis (2100)

Event Date 04/28/2013

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 51-104110 tprlc 133 t1 pps ho 11 x 142 mm, 650-1056 cer bioloxd option hd 32 mm, 13-104050 m/h radial solid/apx shl 50 mm, unknown e1 liner.The complaint cannot be confirmed since operative notes or x-rays were not provided from the event.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-05602, 0001825034-2018-05603, 0001825034-2018-05604, 0001825034-2018-05605.

Event Description

It was reported that approximately 6 months post implantation, the patient was noted to have developed a dvt, and cellulitis to the foot, leg, hip, back, and neck.Attempts have been made and no further information has been provided.

• Brand Name: CER OPTION TYPE 1 TPR SLEVE -3
• 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: 7877100
• MDR Text Key: 120283587
• Report Number: 0001825034-2018-08930
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK082996
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/14/2018

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: 650-1065
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/15/2018
• Initial Date FDA Received: 09/14/2018
• 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 Age: 72 YR
• Patient Weight: 79