MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CER BIOLOXD OPTION HD 36MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Urinary Retention (2119)

Event Date 01/07/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted.Item number: unknown, item name: unknown cup, lot #: unknown; item number: unknown, item name: unknown head, lot #: unknown; item number: unknown, item name: unknown liner, lot #: unknown; item number: unknown, item name: unknown mallory head stem, lot #: unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 07281; 0001825034 - 2018 - 07283; 0001825034 - 2018 - 07284.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported patient continued to experience bladder retention issues approximately one month post-revision surgery.Attempts have been made and no additional information is available.

Manufacturer Narrative

(b)(4).Concomitant medical products: item# 650-1066 cer opt type 1 tpr sleve 0mm lot# unknown.Reported event was unable to be confirmed due to limited information received from the customer.Op note indicated no surgical complications or significant findings noted.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.Additional mdr report was filed for this event, please see associated report: 0001825034 - 2018 - 09717.

• Brand Name: CER BIOLOXD OPTION HD 36MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7765202
• MDR Text Key: 116530868
• Report Number: 0001825034-2018-07285
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: PK082996
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup
• Report Date: 10/15/2018

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: 650-1057
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/12/2018
• Initial Date FDA Received: 08/08/2018
• Supplement Dates Manufacturer Received: 09/21/2018
• Supplement Dates FDA Received: 10/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 138