MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA TIBIA CEMENTED 5 DEGREE STEMMED LEFT SIZE C; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Ambulation or Postural Difficulties (2544); Insufficient Information (4580)
Date of Event	07/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant devices -psn asf ps 10mm ve l 6-9 cd ,catalog #: 42-5124-005-10 lot #: 63449757.The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the surgeon requested to give to patient.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 that a patient recently presented with a collapsed and loosened tibial component and was revised.Attempts have been made but no further information is available at this time.
Event or Problem Description
It was reported that the initial left total knee arthroplasty was performed approximately four and a half years prior to revision.The patient did well for 4 years or so and only recently presented with pain and gait issues.X-rays noted significant findings of osteopenia, subsidence, radiolucency, and loosening.The tibia stem, tibial augment, and ps surface were exchanged.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.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 is being submitted to relay additional information.Updated: b4, b5, g3, g6, h1, h2, h3, h6, and h10.The results of the investigation are as follows: - 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.- radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: significant tibial component loosening with medial subsidence, osteopenia but no fracture seen, significant lucency at the cement hardware interface, and no device deficiency or anatomy concerns.- a definitive root cause cannot be determined.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: PERSONA TIBIA CEMENTED 5 DEGREE STEMMED LEFT SIZE C
• 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: 12332770
• Report Number: 0001822565-2021-02271
• Device Sequence Number: 4712592
• Product Code: MBH
• UDI-Device Identifier: 00889024471016
• UDI-Public: (01)00889024471016(17)260228(10)63277165
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K172524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/22/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2026
• Device Model Number: N/A
• Device Catalogue Number: 42532006401
• Device Lot Number: 63277165
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/22/2021
• Supplement Date Received by Manufacturer: 08/18/2021; 10/19/2021
• Initial Report FDA Received Date: 08/17/2021
• Supplement Report FDA Received Date: 09/02/2021; 11/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2016
• 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.; UNKNOWN PALACOS CEMENT.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 84 KG