MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MOD ARTHRO 0 DEG LCK; ARTHRODESIS NAIL, STERILE

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was not returned by the facility.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 the patient was revised 3 months post revision due to loosening.No additional information available.Previously, the patient underwent a knee replacement procedure.The patient spun into external rotation and was revised approximately 5 months post implantation.It was also noted- hcp used a dual compress mod a intercalary segment as a mid shaft femur intercalary.It was known to be off label.
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.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.The reported products were reviewed for compatibility: as stated in the compress segmental femoral replacement system instructions for use, the compress system is meant for femoral segmental fixation, not for use in the tibia (as in this complaint).Although the device is not marketed to be used in the tibia, the devices are functionally compatible and would not have led to the reported issue.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Medical records were not provided.This complaint cannot be confirmed.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.Additional associated products cp260607 mod arthro nl 3cm diasl cnctr lot# 303070 150482 oss 4cm diaphyseal segment lot# 289650 cp260607 mod arthro nl 3cm diasl cnctr lot# 880390 178711 cps/oss 5cm tpr adapt w/oss sc lot# 932540 178711 cps/oss 5cm tpr adapt w/oss sc lot# 286250 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: MOD ARTHRO 0 DEG LCK
• Common Device Name: ARTHRODESIS NAIL, STERILE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13601094
• Report Number: 0001825034-2021-03304
• Device Sequence Number: 16633293
• Product Code: JDC
• UDI-Device Identifier: 00880304082977
• UDI-Public: (01)00880304082977(17)291211(1
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K043547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: CP260600
• Device Lot Number: 942340
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2021
• Supplement Date Received by Manufacturer: 04/19/2022
• Initial Report FDA Received Date: 02/25/2022
• Supplement Report FDA Received Date: 04/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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
• Patient Age: 50 YR
• Patient Sex: Female