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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Pain (1994); Synovitis (2094); Swelling/ Edema (4577)
Date of Event	11/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date of birth - unknown day in march (b)(6).Concomitant medical products: unknown cement catalog #: n/i, lot #: n/i.Report source: foreign: (b)(6).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.Reference reports: 0001822565 - 2021 - 02157, 0002648920 - 2021 - 00209.
Event or Problem Description
A clinical study patient underwent a primary right total knee arthroplasty.Subsequently, the patient developed swelling, pain and ossification of medial femoral condyle approximately 3 years later and underwent a surgical procedure on an unknown date to remove it.Implant remains implanted and report indicates reported event is resolved now.Attempts have been made, but there is no additional information at this time.
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, b6, e1, e2, e3, e4, g3, g6, h1, h2, and h10.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.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 related to the reported event.Review of the available medical records identified the following: indicates surgery to remove it.Severe medical joint line pain, synovitis and swelling.Pain in medial femoral condyle, there is an ossification that it is going to be surgically removed.4yr visit indicates mild medial joint line pain.Radiology report no abnormal findings noted.Devices remain implanted.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: overall fit and alignment of the implants is appropriate.Question mild osteopenia.No signs of heterotopic ossification.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 RIGHT SIZE G
• 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: 12293784
• Report Number: 0001822565-2021-02164
• Device Sequence Number: 3962770
• Product Code: JWH
• UDI-Device Identifier: 00889024471108
• UDI-Public: (01)00889024471108(17)260731(10)77004960
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K122765
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/17/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2026
• Device Model Number: N/A
• Device Catalogue Number: 42532007902
• Device Lot Number: 77004960
• 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: 07/13/2021
• Supplement Date Received by Manufacturer: 09/05/2021; 11/02/2021
• Initial Report FDA Received Date: 08/09/2021
• Supplement Report FDA Received Date: 09/29/2021; 11/19/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2016
• 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.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 90 KG