MAUDE Adverse Event Report: BIOMET MICROFIXATION HTR * PMI ACEBO SAENZ BI-FRONTAL PARIETAL IMPLANT; HARD TISSUE REPLACE(HTR(R))-PATIENT-MATCH IMPLANT

Model Number N/A

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Ulceration (2116); Discharge (2225)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: biomet microfixation neuro plates, catalog #: ni, lot #: ni; biomet microfixation neuro screws, catalog #: ni, lot #: ni.(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted in the patient.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It is reported a second revision will occur due to an infection."[the first implant] evolves satisfactorily, without infection data coronal flap healing, absence of collection data demonstrated by ct and mri.Given this panorama it was decided to place the second implant [during the fourth quarter of] 2017.The patient evolved with scar healing until [approximately a month following the implantation] until [approximately a month later] in which there appears a frontal ulceration approximately five cm anterior to the coronal access scar with serous material, pending result of culture of exudate, there is also diffuse cutaneous flushing in the coronal flap.The patient will again submit to surgical treatment for removal of the implant in the near future, having completed the pre-operative study protocol.".

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following section was corrected: date received by manufacturer was corrected from dec 8, 2017 to nov.22, 2017.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of photographs and physicians notes.No product was returned and no tests or inspections could be performed.The exact identity of the plates could not be identified as the pictured plates appear to have been cut.The exact identity of the screws could not be identified as the length of the screws could not be determined from the provided pictures.In the physicians report provided, the surgeon reported in the initial revision the implant was removed, purulent exudate was discovered intraoperatively between the coronal flap and the implant, and haemopurulent exudate was also discovered under the implant.In both situations, the culture tested positive for staphylococcus aureus.It was also reported that the coronal flap healed and there was no evidence of the infection.The patient continued to heal well until about a month postoperatively when a 5cm frontal ulceration appeared anterior to the coronal access and serous fluids present that were sent out for a culture.The surgeon also mentions "diffuse cutaneous flushing in the coronal flap" which seems to indicate that there was cutaneous flushing performed near the wound.The physicians report also contained pictures.Figure two shows infected tissue in the area of the implant and figure three shows haemopurulent exudate seeping from the wound in the initial revision.Figure four shows 5cm frontal ulceration appeared anterior to the coronal access and serous fluids.Device history record (dhr) was reviewed and no discrepancies were found.The most likely underlying cause of this complaint is due to infection, which is considered a patient condition.It is unlikely that this infection is implant related as all htr-pmi products are distributed sterile and staphylococcus aureus is often related to hospital acquired infections.The sterile certificates of this htr-pmi were reviewed and no anomalies were found.The instructions for use (ifu) for this product provides situations were this product should not be used.It states in the section titled contraindications this device is contraindicated under any of the following conditions: infection and sepsis, distant foci of infection which can spread to the implant site.It also states in the section titled possible adverse effects: infection can lead to failure of the procedure.And intraoperative and early postoperative complications can include: fracture of bone or soft tissue damage.Dehiscence of the incision.Infection.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.

• Type of Device: HARD TISSUE REPLACE(HTR(R))-PATIENT-MATCH IMPLANT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 7160391
• MDR Text Key: 96334331
• Report Number: 0001032347-2018-00002
• Device Sequence Number: 1
• Product Code: KKY
• Combination Product (y/n): N
• PMA/PMN Number: PK924935
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 06/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/28/2019
• Device Model Number: N/A
• Device Catalogue Number: PM617732
• Device Lot Number: 674830
• Other Device ID Number: (01)00841036208226
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 29 YR