MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CER OPT TYPE 1 TPR SLEVE 0MM; PROSTHESIS HIP

Model Number N/A

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

Patient Problem Cellulitis (1768)

Event Date 11/24/2012

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 with the information 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.Medical devices: 51-104110, tprlc 133 t1 pps ho 11x142mm, unk; 650-1056, cer bioloxd option hd 32mm, unk; 13-104050, m/h radial solid/apx shl 50mm, unk; item #, liner, lot # unk.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 05574 ; 0001825034 - 2018 - 05575; 0001825034 - 2018 - 05576; 0001825034 - 2018 - 05577.

Event Description

It was reported that approximately 2 months post implantation, the patient developed cellulitis to the affect hip and required antibiotic treatment.Attempts have been made and no further information has been provided.

• Brand Name: CER OPT TYPE 1 TPR SLEVE 0MM
• 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: 7943093
• MDR Text Key: 123051460
• Report Number: 0001825034-2018-09522
• 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: 10/08/2018

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: 650-1066
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/10/2018
• Initial Date FDA Received: 10/08/2018
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 52 YR
• Patient Weight: 101