MAUDE Adverse Event Report: TORNIER S.A.S. CEMENT RESTRICTOR DIAM.13MM; CEMENT OBTURATOR

Model Number EBO102

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

Patient Problem Bacterial Infection (1735)

Event Date 11/24/2021

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.Device discarded.

Event Description

It was reported that the patient had to undergo a revision surgery due to a free floating screw from the ulnar cap.Following this surgery the patient had to undergo another revision due to staphylococcus epidermidis.The initial plan was to swap the spool and cap, however the infection loosened the humeral and ulnar components.Components were removed and an antibiotic cement spacer was placed insitu.The patient will be need a subsequent operation after infection clears to have new components implanted.

Event Description

It was reported that the patient had to undergo a revision surgery due to a free floating screw from the ulnar cap.Following this surgery the patient had to undergo another revision due to staphylococcus epidermidis.The initial plan was to swap the spool and cap, however the infection loosened the humeral and ulnar components.Components were removed and an antibiotic cement spacer was placed insitu.The patient will be need a subsequent operation after infection clears to have new components implanted.

Manufacturer Narrative

The reported event could not be confirmed since the device was not returned for evaluation and no other evidence was provided for evaluation.A device inspection was not possible since the affected device was not returned, and no other evidences were provided for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.More information as well as the affected device must be available in order to determine the exact root cause of the alleged failure.However, based on the clinical opinion on the potential risk of infection caused by sterile packed stryker implants and instruments, ¿any kind of surgery bears the risk of infection.In trauma and orthopedic surgery with external or internal fixation implants or endoprostheses the infection risk varies between 0.5 % and 5 %, exceptionally up to 10 % and beyond, mainly depending on the respective surgical procedure and the typical patient population.¿ a review of the labeling did not indicate any abnormalities.In case the item and / or substantive information will become available in future that suggests otherwise; the file will be reviewed.

• Brand Name: CEMENT RESTRICTOR DIAM.13MM
• Type of Device: CEMENT OBTURATOR
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer (Section G): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer Contact: nathe hendricks ; 11576 memphis arlington rd; arlington, TN 38002 ; 9018679971
• MDR Report Key: 13057013
• MDR Text Key: 282698390
• Report Number: 3000931034-2021-00360
• Device Sequence Number: 1
• Product Code: LZN
• UDI-Device Identifier: 03700386928710
• UDI-Public: 03700386928710
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K061824
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: EBO102
• Device Catalogue Number: EBO102
• Device Lot Number: 8280AV064
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male