MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA REV TIB FIX NP SZ C R; PROSTHESIS, KNEE

Catalog Number	42542006402
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient reported moderate pain to the knee with extreme pain standing upright and bending to the floor during the two years follow up.The patient has improved as the study continued, all radiographic imaging displays no significant findings, and all products remain implanted.
Additional Manufacturer Narrative
D10: additional associated products.42504605802, persona rev fem cmt ccr std sz 5r lot# 64888669.42540000032, persona all poly pat ply 32mm lot# 64843506.42560007514, persona rev str smth stem 14x75 lot# 64835182.42556605810, persona fem distal aug sz5 10mm lot# 64859429.42556605810, persona fem distal aug sz5 10mm lot# 64817459.42560007514, persona rev str smth stem 14x75 lot# 64911499.
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.The following sections were updated/corrected: updated: b4, b5, d5, g3, g6, h1, h2, h3, h6, h10, h11.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.The reported products were reviewed for compatibility with no issues noted.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: visit 1; follow-up: moderate-occasional pain, xr- no significant findings, rom 2-110, healing well.Visit 2; follow-up: moderate pain, extreme pain standing upright, severe pain bending to floor, xr- no significant findings, the symptoms began gradually over time.Symptoms began 1 year ago.Pain is moderate with a rating of 8/10.Pain sharp, throbbing, aching and burning.The symptoms are constant.Since the onset, she reports the problem is getting worse.The symptoms are made worse with bending, walking and standing.The patient experiences swelling, numbness, stiffness, limping, clicking and tingling.Prior testing: no diagnostic tests have been performed.Pain is intermittent.After she has been walking for long time.She has some swelling.She has outstanding range of motion however.She feels very stable.(some swelling post- activity is not an abnormal finding and within the note is not calling it out as a complication).10-apr-2024; follow-up: mild pain, moderate pain straightening knee, going up/down stairs, and standing upright, exam: no swelling, ecchymosis or deformity, rom 0-125, stable varus/valgus, gait normal, xr: implant in good position and alignment with no gross evidence of failure or loosening.Visit 3; follow-up: mild-occasional pain, xr: implants in good position and alignment without evidence of failure, loosening, or fracture, exam wnl, rom 0-125.The event is confirmed.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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 REV TIB FIX NP SZ C R
• 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: 22077611
• Report Number: 0001822565-2025-01538
• Device Sequence Number: 9337977
• Product Code: JWH
• UDI-Device Identifier: 00889024562868
• UDI-Public: (01)00889024562868(17)300916(10)64827455
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K191625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 10/09/2025

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
• Device Catalogue Number: 42542006402
• Device Lot Number: 64827455
• 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: 05/01/2025
• Supplement Date Received by Manufacturer: 09/11/2025
• Initial Report FDA Received Date: 05/23/2025
• Supplement Report FDA Received Date: 10/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2020
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 88 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White