MAUDE Adverse Event Report: BIOMET MICROFIXATION 1.5 LACTOSORB SYSTEM CURVED PLATE - 6 HOLE; PLATE, FIXATION, BONE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products - unknown biomet microfixation lactosorb screws catalog #: ni, lot #: ni.The user facility is foreign; therefore a facility medwatch report will not be available.Report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation as it was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a revision occurred due to the patient contracting an infectious disease.Approximately four months ago, the surgeon detected the patient had (b)(6), streptococcus intermedius and peptostreptococcus micros.The patient was treated with antibiotics but was revised approximately three weeks ago due to insufficient recovery.Cultures have been taken but the results have not been obtained yet.No additional patient consequences were reported.
Event or Problem Description
This follow-up report is being submitted to relay additional information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Because it was reported that a revision surgery occurred, the complaint is confirmed.The dhr for the plate was reviewed, no non-conformances were found.For this part (915-2427) and the previous one year (from the notification date), there is a complaint rate of 0.213% regarding an infection which is no greater than the occurrence listed in the application fmea.The most likely underlying cause of the complaint cannot be determined, however, it was reported that it was believed the lactosorb product did not cause/contribute to the infection.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.

• Brand Name: 1.5 LACTOSORB SYSTEM CURVED PLATE - 6 HOLE
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8616820
• Report Number: 0001032347-2019-00283
• Device Sequence Number: 16899020
• Product Code: HRS
• UDI-Device Identifier: 00841036055677
• UDI-Public: 00841036055677
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K971870
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/15/2022
• Device Model Number: N/A
• Device Catalogue Number: 915-2427
• Device Lot Number: 318030
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/17/2019
• Supplement Date Received by Manufacturer: 08/15/2019
• Initial Report FDA Received Date: 05/16/2019
• Supplement Report FDA Received Date: 08/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention