MAUDE Adverse Event Report: BIOMET MICROFIXATION 2.0 LACTOSORB SYSTEM L-PLATE - RIGHT - REGULAR; PLATE, FIXATION, BONE

Model Number N/A

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

Patient Problems Unspecified Infection (1930); Inflammation (1932)

Event Date 12/03/2020

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2020-00630, 0001032347-2020-00631, 0001032347-2020-00632, 0001032347-2020-00633.Explantation date ¿ the customer reported two dates for the revision surgery: (b)(6) 2020.Clarification was requested from the customer and no response has yet been received.Medical products: 2.0 lactosorb system l-plate - right - regular, part# 915-2101, lot# 835610.2.0 lactosorb system straight plate - 6 hole, part# 915-2109, lot# 956850.2.0 lactosorb system straight plate - extended - 4 hole, part# 915-2111, lot# 145750.2.0 lactosorb system straight plate - extended - 4 hole, part# 915-2111, lot# 372990.2.0 lactosorb system straight plate - extended - 6 hole, part# 915-2112, lot# 499780.The user facility is foreign; therefore, a facility medwatch report will not be available.Foreign report source: (b)(6).

Event Description

It was reported that infection and inflammation were discovered nine (9) days following implantation of plates and screws and a removal was planned two (2) weeks following implantation.The surgeon is uncertain as to the cause of the infection and thinks it is possible that the plates and screws are the cause of the infection.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; g3; g6; h1; h2; h3; h6 no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.Review of the device history records and sterile certificates identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.Single-use, sterilized devices manufactured or distributed by zimmer biomet are sterilized in accordance with fda regulations and iso standards to a sterility assurance level of 1.0 x 10-6 or better.Therefore, it is unlikely that the specified device caused any patient infection.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

No further event information available at the time of this report.

• Brand Name: 2.0 LACTOSORB SYSTEM L-PLATE - RIGHT - REGULAR
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 11086849
• MDR Text Key: 224513868
• Report Number: 0001032347-2020-00629
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00841036054397
• UDI-Public: 00841036054397
• Combination Product (y/n): N
• PMA/PMN Number: K955729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 03/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• 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: 835610
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/26/2021
• 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