MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MOD ARTHRO NL 3CM ELIP CNCTR; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Failure of Implant (1924)
Date of Event	08/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: cp260601 - mod arhthro 5 deg lck collar - 658250.Cp260608 - mod arthro nl 3cm elip cnctr - 871520.The customer has indicated that the product will not be returned to zimmer biomet for investigation, as it was not returned by the hospital.The investigation is in process.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: 0001825034-2021-02546.
Event or Problem Description
It was reported that the patient underwent a revision surgery because the oss arthrodesis connector / coupler broke.X-rays also show a cortical fracture of the distal femur.It was reported that no further information is available.
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.The dhr was reviewed and no discrepancies relevant to the reported event were found.X-rays were provided and reviewed by a health care professional.Review found abnormal angulation of the femoral implant connector consistent with implant discontinuity and a cortical fracture of the distal femur.Bone quality is osteopenic.X-ray evaluation is limited due to the views provided and quality.The allegation of implant fracture was not able to be confirmed in the x-rays.Medical records were not provided.A definitive root cause cannot be determined.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: MOD ARTHRO NL 3CM ELIP CNCTR
• Common Device Name: PROSTHESIS, KNEE
• 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: 12391350
• Report Number: 0001825034-2021-02547
• Device Sequence Number: 14354921
• Product Code: HSB
• UDI-Device Identifier: 00880304083059
• UDI-Public: (01)00880304083059(17)270911(10)871510
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K042409
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 01/12/2022

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: CP260608
• Device Lot Number: 871510
• 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: 08/09/2021
• Supplement Date Received by Manufacturer: 01/11/2022
• Initial Report FDA Received Date: 08/31/2021
• Supplement Report FDA Received Date: 01/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2017
• 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 Sex: Male