MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK TM SHELL 54MM; PROSTHESIS, HIP

Model Number N/A

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

Patient Problems Hematoma (1884); Impaired Healing (2378)

Event Date 09/05/2011

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00630505036 liner standard 3.5 mm offset 36 mm i.D.For use with 50/52/54 mm o.D.Shells, 00625006535 bone screw self-tapping 6.5 mm dia.35 mm length, 00625006520 bone screw self-tapping 6.5 mm dia.20 mm length.Report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the device remains imlanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2019 - 05180, 0001822565 - 2019 - 05181, 0001822565 - 2019 - 05182.

Event Description

It was reported patient underwent surgical evacuation of a superficial postop hematoma and debridement of wound dehiscence approximately one year post implantation.No product was revised, and the patient was discharged without further complication.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: h2; h3; h6.Reported event was confirmed by review of medical records received.Review of the available records identified the patient underwent a right total hip arthroplasty revision due to periprosthetic infection.The patient then underwent wound dehiscence, hematoma removal, debridement, and drainage.There was no suspicion of infection and secretions stopped after the surgical intervention.No product was revised.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.A definitive root cause cannot be determined.The reported event is a procedure related complication and/ or non-device related.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.

Event Description

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

• Brand Name: UNK TM SHELL 54MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9434824
• MDR Text Key: 169850381
• Report Number: 0001822565-2019-05183
• Device Sequence Number: 1
• Product Code: JDI
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/28/2020

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: 11/13/2019
• Initial Date FDA Received: 12/07/2019
• Supplement Dates Manufacturer Received: 01/02/2020
• Supplement Dates FDA Received: 01/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention