MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN CUP; PROSTHESIS, HIP

Model Number N/A

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

Patient Problem Seroma (2069)

Event Date 02/26/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: unknown head, pn unknown, ln unknown; unknown stem, pn unknown, ln unknown; unknown liner, pn unknown, ln unknown.Multiple mdr reports were filed for this event, please see associated reports 0001825034-2019-03616, 0001825034-2019-03617, 0001825034-2019-03619.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient underwent an i&d approximately two weeks post-implantation due to a seroma of the surgical site.Attempts have been made and additional information on the reported event is unavailable at this time.No further information is available.

Manufacturer Narrative

(b)(4).Reported event was confirmed due medical records that were provided and reviewed by a health care professional.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.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmerbiomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

• Brand Name: UNKNOWN CUP
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8896894
• MDR Text Key: 154432070
• Report Number: 0001825034-2019-03618
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 09/16/2019

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/22/2019
• Initial Date FDA Received: 08/15/2019
• Supplement Dates Manufacturer Received: 09/09/2019
• Supplement Dates FDA Received: 09/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Weight: 117