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 04/22/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical devices: item # 51-145090, stem, lot # unk; item # unk, shell, lot # unk; item # unk, liner, lot # unk.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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 - 05754; 0001825034 - 2018 - 05756; 0001825034 - 2018 - 05757.

Event Description

It was reported that approximately 6 weeks post implantation, the patient developed urinary retention that required a urethral procedure.Attempts have been made and no further information has been provided.

Manufacturer Narrative

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.Concomitant medical products: item # 650-1064, taper, lot # unk, item # 13-104054, cup, lot # unk, item # 51-107140, stem, lot # unk.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 09262.

• 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: 7767424
• MDR Text Key: 116556204
• Report Number: 0001825034-2018-05755
• 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: 10/01/2018

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: 08/09/2018
• Supplement Dates Manufacturer Received: 09/06/2018
• Supplement Dates FDA Received: 10/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Weight: 77