MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FIX PIN FLTD 3.2DX150MM 2 PACK; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	04/27/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the event occurred after an initial knee operation and patient was operated with a periprosthetic plate due to a stress fracture of the left femur.Surgical report details that the fracture occurred at the femoral fiches which are the pins used in rosa instrumentation.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 42532006401- tibia cemented 5 degree stemmed left size c- 64802885; 42500605401- femur cemented posterior stabilized (ps) standard left size 3- 64432733; 42511400414- articular surface fixed bearing posterior stabilized (ps) left 14 mm height- 64849957.Customer has indicated that the product will not be returned to zimmer biomet for investigation, rosa platforms remain at hospitals.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No additional event information to report at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.G2: report source italy.Visual analysis of the photos/xrays provided by the user confirmed that there is a fracture on the femoral bone of the implanted leg, confirming the reported event.Review of the device history record identified no deviation and/or anomalies related to the reported complaint event.A definitive root cause could not be determined with the information available.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.

• Brand Name: FIX PIN FLTD 3.2DX150MM 2 PACK
• 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: 13053696
• Report Number: 0001822565-2021-03631
• Device Sequence Number: 4153401
• Product Code: OLO
• UDI-Device Identifier: 00889024563629
• UDI-Public: (01)00889024563629(17)250928(10)64902357
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K182964
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2022
• 2 Devices were Involved in the Event: 1 2

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: 09/28/2025
• Device Model Number: N/A
• Device Catalogue Number: 20-8000-000-10
• Device Lot Number: 64902357
• 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: 12/06/2021
• Supplement Date Received by Manufacturer: 07/20/2022
• Initial Report FDA Received Date: 12/21/2021
• Supplement Report FDA Received Date: 07/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown