MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CER OPTION TYPE 1 TPR SLEVE -6; PROSTHESIS, HIP

Model Number N/A

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

Patient Problem Cellulitis (1768)

Event Date 12/06/2011

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 not possible as the necessary product/lot code combination was not provided.Root cause was unable to be determined as the necessary information to adequately investigate the reported event 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: item # 51-104110, item name tprlc 133 t1 pps ho, 11x142mm, lot unk.Item # 650-1058, item name cer bioloxd option, hd 40mm, lot / software release # unk.Not returned to manufacturer.

Event Description

It was reported the patient developed cellulitis requiring admission for antibiotic treatment.No further information available.

• Brand Name: CER OPTION TYPE 1 TPR SLEVE -6
• 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: 7931725
• MDR Text Key: 122620881
• Report Number: 0001825034-2018-09419
• 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: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/03/2018

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: 650-1064
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/07/2018
• Initial Date FDA Received: 10/03/2018
• 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): Hospitalization; Required Intervention
• Patient Age: 54 YR
• Patient Weight: 150