MAUDE Adverse Event Report: BIOMET MICROFIXATION LACTOSORB TRAUMA PLATING SYSTEM; LACTOSORB 2.0 L-PLATE RIGHT REGULAR

Model Number N/A

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

Patient Problems Inflammation (1932); Pain (1994); Osteolysis (2377)

Event Date 09/08/2017

Event Type  Injury  

Manufacturer Narrative

A photograph of one of the devices was provided.The photograph was reviewed by the research director; he stated, "in looking at the picture, i am not sure of the scale but it appears that if the picture is of one of the l-plates, then the material is resorbing as it is supposed to." in regards to the osteolysis, he states, "the revision surgery was done with removal of the plate approximately 8 months after implant with the surgeon indicating that there was osteolysis/bone resorption.It is unlikely that the lactosorb material was the source of this because of the very short timeframe after implantation and the fact that the polymer material is biocompatible and is hydrolyzed naturally by the body over time without the creation of wear debris." the user facility is foreign; therefore a facility medwatch report will not be available.Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.This is report one of five for the same event; reference reports 0001032347-2017-00747 through 0001032347-2017-00750.

Event Description

It was reported the original surgery was performed on (b)(6) 2017.Six months post operative the patient complained of pain in the right maxilla.The surgeon examined the patient and confirmed inflammation.The surgeon treated the patient with antibiotics, however it did not recover.Therefore, a revision was performed on (b)(6) 2017.The revision was completed and all devices were removed.It is reported there was a surgical delay over thirty minutes during the revision surgery.The surgeon confirmed osteolysis or bone resorption around screw holes while removing the screws.Additional information was requested but has not been received at this time.

Manufacturer Narrative

Zimmer biomet complaint (b)(4).This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of picture provided.The picture appears to be a fragment of these implants, however no conclusion can be reached as to the identity of this fragment or cause of this complaint due to the poor quality and limited content of the picture.No product was returned and no functional tests or inspections could be performed.No x-rays, scans, physicians reports, or additional pictures were provided.Review of the complaint history determined that no further action is required as no trends were identified.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.A summary of the investigation has been sent to the complainant.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.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2017-00747-1 through 0001032347-2017-00750-1.

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Report source: foreign country: (b)(6).This follow-up report is being submitted to relay additional information.The lot number involved in the event is unable to be confirmed, however the distributor provided a potential lot of 246020, manufactured may 19, 2016 with a sterile expiration date of may 19, 2021.Device history record (dhr) was reviewed and no discrepancies were found.(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2017-00747-2, 0001032347-2017-00748-2, 0001032347-2017-00749-2, and 0001032347-2017-00750-2.

Event Description

Additional information was received that the patient is still experiencing swelling again in spite of the revision surgery.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Small fragments of white materials chalk like material were returned in a biohazardous condition.It was reported the fragments are of part number 915-2101.The returned materials appearance may be consistent with some lactosorb product that has been implanted for eight months; however this could not be confirmed due to the damaged and biohazardous nature of the returned product.No functional tests could be performed and no conclusions could be reached on the product that was returned.Root cause was unable to be determined.A summary of the investigation has been sent to the complainant.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: LACTOSORB TRAUMA PLATING SYSTEM
• Type of Device: LACTOSORB 2.0 L-PLATE RIGHT REGULAR
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: michelle cole ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 6913387
• MDR Text Key: 88115284
• Report Number: 0001032347-2017-00746
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK955729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/06/2018

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
• Device Catalogue Number: 915-2101
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/12/2017
• Initial Date FDA Received: 10/04/2017
• Supplement Dates Manufacturer Received: 01/31/2018; 03/30/2018; 06/01/2018
• Supplement Dates FDA Received: 02/22/2018; 04/26/2018; 08/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 44 YR