MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA REVISION UNCEMENTED OFFSET SPLINED STEM EXTENSION 3MM X 15MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994); Loss of Range of Motion (2032); Swelling/ Edema (4577)
Date of Event	07/14/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that one day following right knee arthroplasty, it was identified that the patient had experienced a tibial shaft fracture during implantation of the tibial stem after reviewing post-operative x-rays.The patient was placed on non-weightbearing restrictions and advised to utilize a walking boot for stabilization with continued physical therapy.The fracture healed within a few months.Operative notes from the procedure noted no intraoperative complications.The patient achieved full range of motion and good stability with placed components.No additional patient consequences were reported.
Additional Manufacturer Narrative
(b)(4).Concomitant devices - persona revision cemented offset splined stem extension 6mm x 17mm catalog #: 42560613517 lot #: 64567586, persona revision standard femoral component right size 7 catalog #: 42504606202 lot #: 64267878, persona revision cemented tibial augment half block right lateral size cd 10mm catalog #: 42555803210 lot #: 64695990, persona revision cemented tibial augment half block right medial size cd 10mm catalog #: 42555803410 lot #: 64661875, persona revision tibial central cone size x-small catalog #: 42545000510 lot #: 64643012, persona revision cemented tibial component right size d catalog #: 42542006702 lot #: 64326744, persona revision constrained fixed bearing articular surface right 14mm catalog #: 42522800514 lot #: 64277780.The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.H6 - component code - proposed code is mechanical (g04) - stem.Review of medical records received confirmed the patient's post-operative fracture.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information provided.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.

• Brand Name: PERSONA REVISION UNCEMENTED OFFSET SPLINED STEM EXTENSION 3MM X 15MM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15002637
• Report Number: 0001822565-2022-02015
• Device Sequence Number: 1563206
• Product Code: JWH
• UDI-Device Identifier: 00887868250057
• UDI-Public: (01)00887868250057(17)300630(10)64769714
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K191625
• 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: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/12/2023

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 Model Number: N/A
• Device Catalogue Number: 42560313515
• Device Lot Number: 64769714
• 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: 06/17/2022
• Supplement Date Received by Manufacturer: 10/05/2022; 03/23/2023
• Initial Report FDA Received Date: 07/13/2022
• Supplement Report FDA Received Date: 10/11/2022; 04/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2020
• 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: Required Intervention
• Patient Sex: Female
• Patient Weight: 93 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White