MAUDE Adverse Event Report: BIOMET MICROFIXATION 2.0 LACTOSORB SYSTEM STRAIGHT PLATE - EXTENDED - 4 HOLE; PLATE, FIXATION, BONE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inflammation (1932)
Date of Event	12/03/2020
Type of Reportable Event	Serious Injury
Additional 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: 0001032347-2020-00629, 0001032347-2020-00630, 0001032347-2020-00631, 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 or Problem 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.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 or Problem Description
No further event information available at the time of this report.

• Brand Name: 2.0 LACTOSORB SYSTEM STRAIGHT PLATE - EXTENDED - 4 HOLE
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 11086856
• Report Number: 0001032347-2020-00632
• Device Sequence Number: 3754341
• Product Code: HRS
• UDI-Device Identifier: 00841036054564
• UDI-Public: 00841036054564
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K955729
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2021

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: 01/17/2024
• Device Model Number: N/A
• Device Catalogue Number: 915-2111
• Device Lot Number: 372990
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/04/2020
• Supplement Date Received by Manufacturer: 02/26/2021
• Initial Report FDA Received Date: 12/29/2020
• Supplement Report FDA Received Date: 03/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention