MAUDE Adverse Event Report: BIOMET ORTHOPEDICS 4.5MM CORT NON-LOCK SCREW 28MM; DEVICE, FIXATION

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Hematoma (1884); Pain (1994); No Information (3190)

Event Date 02/16/2016

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 2 states, "bending or fracture of the implant." (b)(6).This report is number 3 of 3 mdrs filed for the same event (reference 1825034-2016-02283/02247/02246).Additional mdr filed for the same patient (reference 1825034-2016-02277).Remains implanted.

Event Description

Patient underwent a debridement procedure approximately six months post implantation.During the procedure, it was noted a screw was fractured.There was no loosening of the plate, so the plate and screws remain implanted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.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

Patient underwent a debridement procedure approximately six months post implantation due to hematoma of the left thigh which caused pain.During the procedure, it was noted a screw was fractured.There was no loosening of the plate, so the plate and screws remain implanted.

Manufacturer Narrative

(b)(4).Concomitant medical products: catalog #: 15-105052, m2a 38mm one piece cup sz 52mm, lot # 049720, catalog #: unknown, unknown stem, lot # unknown, catalog #: 11-150844, biomet arcom patella, lot # 038760.Reported event was unable to be confirmed due to limited information received from the customer.Also, x-rays were reviewed and noted to have no fractures.A product search was ran and it was found that the reported devices were recalled (b)(6), 2016.Device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not 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.

Manufacturer Narrative

Reported event was unable to be confirmed; no product was returned so visual and dimensional evaluations could not be performed; x-rays were reviewed, however, no fracture was identified.Device history records were reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No additional information received.

• Brand Name: 4.5MM CORT NON-LOCK SCREW 28MM
• Type of Device: DEVICE, FIXATION
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 5748336
• MDR Text Key: 48130443
• Report Number: 0001825034-2016-02246
• Device Sequence Number: 1
• Product Code: JDO
• Combination Product (y/n): N
• PMA/PMN Number: PK140018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/07/2019

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?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 14-455028
• Device Lot Number: 891630
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/26/2016
• Initial Date FDA Received: 06/24/2016
• Supplement Dates Manufacturer Received: 06/20/2018; 08/08/2018; 05/01/2019
• Supplement Dates FDA Received: 08/13/2018; 09/05/2018; 05/07/2019
• 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: 57 YR
• Patient Weight: 90