MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TI LOW PROFILE SCREW; PROSTHESIS, HIP

Catalog Number 103531

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

Patient Problems Wound Dehiscence (1154); Swelling (2091); Impaired Healing (2378)

Event Date 10/31/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: ti low profile screw cat#103531 lot#547580.Shell with cluster holes cat#00875305001 lot#63861501.Report source: (b)(6).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-05410.

Event Description

It was reported that the patient underwent a full artificial joint replacement and the wound showed repeated symptoms of redness, swelling, rupture and exudation after the operation.Approximately one week later, the patient underwent a dilated and invasive catheter drainage, and the wound healed upon discharge.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

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

Manufacturer Narrative

Udi# (b)(4).Reported event was confirmed with medical records provided.Review of the available records identified the following: patient was diagnosed with anemia and swelling post op.Infection developed shortly after implant procedure.Wound drainage, drainage tube was placed, and treated with antibiotics.Wound healed and patient discharged.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.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.

• Brand Name: TI LOW PROFILE SCREW
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9411095
• MDR Text Key: 169080160
• Report Number: 0001825034-2019-05411
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K082446
• 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: 03/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 103531
• Device Lot Number: 547720
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR