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 Problem Cellulitis (1768)

Event Date 11/05/2012

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 51-107100, tprlc 133 mp type 1 pps ho 17.0, unknown; 650-1057, cer bioloxd option hd 36mm,unknown; unknown, unknown mh shell, unknown; unknown, unknown e1 maxrom liner, unknown.Multiple mdr reports were filed for this event; please see associated reports: 0001825034-2018-06516, 001825034-2018-06522, 0001825034-2018-06523, 0001825034-2018-06517.Customer has indicated that the product will not be returned to zimmer biomet for investigation, [remains implanted].Reported event was unable to be confirmed due to limited information received from the customer.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.

Event Description

It was reported that the patient's right hip was noted to have cellulitis requiring visit to er due to redness around incision on one month post implantation.No further information is available at this time.

• 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: 7915457
• MDR Text Key: 121920897
• Report Number: 0001825034-2018-09215
• 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: 09/27/2018

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/12/2018
• Initial Date FDA Received: 09/27/2018
• 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): Required Intervention
• Patient Age: 61 YR
• Patient Weight: 122