MAUDE Adverse Event Report: EBI, LLC. OSTEOGEN-20/M SURGICALLY IMPLANTED BONE GROWTH STIMULATOR; OSTEOGEN-20/M, BONE STIMULATOR

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 08/21/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device will not be returned for analysis; however, and investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Concomitant medical products - zimmer natural system long blue 130 degree ccd angle.Right.11.5 mm x 40 cm.Zimmer natural system set screw.8 mm diameter 3.5 mm hex head.Bone graft- lifenet health.Morphogenic protein 2 (infuse) - medtronic.Therapy date: (b)(6) 2017.Device was not returned.

Event Description

It was reported that the patient underwent a two stage revision due to infection.The first revision surgery was for placement of the bone stimulator due to atrophic non-union.The subsequent revision surgery occurred 6 months later, for the removal of the bone stimulator, and placement of antibiotic impregnated stem and bead due to infection.No additional patient consequences were reported.

Event Description

It was reported that the patient underwent a two stage revision due to infection.The first revision surgery was for placement of the bone stimulator due to atrophic non-union.During a doctor's office visit, a few months following implantation of the bone stimulator, it was noticed that the patient had a draining wound down the lateral aspect of the hip.She had pain in the right hip region.X- ray images showed a nail stabilizing a subtrochanteric fracture with the tip of the bone stimulator electrode below the fracture site.There was a small amount of ho formation around the electrode.There was presence of an infected nonunion of a right subtrochanteric fracture.The patient was referred to a hospital for explant of the stimulatory, debridement, possible hardware exchange, and long term antibiotics.The subsequent revision surgery occurred 6 after the initial surgery, for the removal of the bone stimulator, and placement of antibiotic impregnated stem and bead due to infection.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Medical record provided more information on the reported event.No product was returned for evaluation and no pictures/x-ray images were provided.An investigation of the reported event is still in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that the patient underwent a two stage revision due to infection.The first revision surgery was for placement of the bone stimulator due to atrophic non-union.During a doctor's office visit, a few months following implantation of the bone stimulator, it was noticed that the patient had a draining wound down the lateral aspect of the hip.She had pain in the right hip region.X- ray images showed a nail stabilizing a subtrochanteric fracture with the tip of the bone stimulator electrode below the fracture site.There was a small amount of ho formation around the electrode.There was presence of an infected nonunion of a right subtrochanteric fracture.The patient was referred to a hospital for explant of the stimulatory, debridement, possible hardware exchange, and long term antibiotics.The subsequent revision surgery occurred 6 months after the initial surgery, for the removal of the bone stimulator, and placement of antibiotic impregnated stem and bead due to infection.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The device was not returned to zimmer biomet for evaluation.The reported event was unable to be confirmed due to limited information from the customer.The device history record (dhr) was reviewed and no discrepancies were found.The root cause is 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 report will be filed accordingly.Zimmer biomet will continue to monitor for trends.The following sections were updated: b4: date of this report.G1-2: name and email address updated.G4: date received by manufacturer added.G7: type of report.H2: follow up type.H3: device evaluated by manufacturer updated to no.H4: device manufacturer date added.H6: device code updated to 3191: appropriate term/code not available.H6: method code updated to 3331: analysis of production records.H6: results code updated to 3221: no findings available.H6: conclusions code updated to 4315: cause not established.H9: recall number added.H10: additional narratives/data h3 other text : the device has not been returned.

• Brand Name: OSTEOGEN-20/M SURGICALLY IMPLANTED BONE GROWTH STIMULATOR
• Type of Device: OSTEOGEN-20/M, BONE STIMULATOR
• Manufacturer (Section D): EBI, LLC.; 399 jefferson road; parsippany NJ 07054
• MDR Report Key: 8453439
• MDR Text Key: 139957759
• Report Number: 0002242816-2019-00007
• Device Sequence Number: 0
• Product Code: LOE
• PMA/PMN Number: 790005/S044
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 12/04/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/04/2017
• Device Model Number: N/A
• Device Catalogue Number: 10-1320M
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0286-2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 109