MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA REVISION TRABECULAR METAL CENTRAL FEMORAL CONE SIZE SMALL; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant devices - persona revision cemented standard femur right size 9 catalog #: 42504606602 lot #: 64626851, persona revision offset splined uncemented stem extension 6mm x 17mm x +175mm catalog #: 42560617517 lot #: 64759641, persona revision posterior cemented femoral augment size 9, 9+ 5mm catalog #: 42556806605 lot #: 64760893, persona revision posterior cemented femoral augment size 9, 9+ 5mm catalog #: 42556806605 lot #: 64661852, persona revision cemented tibia right size e catalog #: 42542007102 lot #: 64394518, persona revision vivacit-e cck articular surface right 18mm with locking screw catalog #: 42522800718 lot #: 64286235, persona revision offset splined uncemented stem extension 3mm x 17mm x 135mm catalog #: 42560313517 lot #: 64769718, unknown palacos bone cement catalog #: ni lot #: ni.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.Multiple mdr reports were filed for this patient; please see all reports associated with this event: 0001822565-2024-00550 0001822565-2024-00551 0001822565-2024-00555 0001822565-2024-00556 0001822565-2024-00557 0001822565-2024-00558 0001822565-2024-00559 h3 other text : investigation incomplete.
Event or Problem Description
It was reported that the patient was treated with topical agents, non-steroidal anti-inflammatory drugs, and narcotics to address limited range of motion and persistent moderate pain approximately two (2) years following the patient's last right knee arthroplasty.No surgical intervention has been reported to date.Operative notes noted no intraoperative complications.
Event or Problem Description
No further event information is available at the time of this report.
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.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Medical records and radiographs were provided and reviewed by a health care professional.Review of the available records identified the - following: prothesis well seated and positioned appropriately with no signs of wear or loosening, narcotics for pain relief, electric shooting, pins/needles, rom 0-95.Radiographs were not reviewed as they are thoroughly covered in medical records.A definitive root cause cannot be determined.The complaint is confirmed via medical records.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 REVISION TRABECULAR METAL CENTRAL FEMORAL CONE SIZE SMALL
• 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: 18730349
• Report Number: 0001822565-2024-00554
• Device Sequence Number: 8275979
• Product Code: JWH
• UDI-Device Identifier: 00889024560789
• UDI-Public: (01)00889024560789(17)291130(10)64500868
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K191625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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
• Report Date (Section B): 06/13/2024

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: 42545001011
• Device Lot Number: 64500868
• 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: 01/22/2024
• Supplement Date Received by Manufacturer: 06/06/2024
• Initial Report FDA Received Date: 02/19/2024
• Supplement Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2019
• 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: 110 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American