MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PSN REV FEM CMT CCR STD SZ 7R; PROSTHESIS, KNEE

Catalog Number	42504606202
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10-medical product: psn rev str smth stem 14x75, item# 42560007514, lot# 64853522.Psn fem distal aug sz7 5mm, item# 42556606205, lot# 64679144.Psn asf cps 10mm ve r 6-9 cd, item# 42522600510, lot# unknown.Psn rev str smth stem 14x75, item# 42560007514, lot# 64853522.Refobacin bc r 1x40 us, item# 110034355, lot# k1905z22ba.Unknown mesh, h3- customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.H6: component code: proposed component (annex g) code is: - mechanical (g04) ¿ femur.
Event or Problem Description
It was reported that patient is experiencing pain approximately two years post implantation.All radiographic imaging displays no significant findings and all products remain implanted.Attempts to obtain additional information have been made; however, no more information is available at this time.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This report is being submitted to provide additional information.Updated: b4, b5, d2, g1, g3, g6, h1, h2, h3, h6, and h11.Corrected: h4.No product was returned, or pictures provided; therefore, visual and dimensional evaluations could not be performed.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: between (b)(6) 2021 and (b)(6) 2025, the patient¿s course was marked by persistent knee pain and progressive hip complications.Early follow-ups in 2021¿2022 showed only mild pain with unremarkable x-rays, though contralateral knee pain was noted in (b)(6) 2022.By late 2022, the patient developed a right hip abscess requiring hardware removal and iv antibiotics, followed by ongoing moderate, continual right knee pain with activity-related exacerbations (particularly twisting, pivoting, standing upright, and stair climbing) reported from (b)(6) 2023 onward, despite consistently normal radiographic findings.Additional events included left tka in (b)(6) 2023 and lumbar surgery in (b)(6) 2024.By (b)(6) 2025, the patient experienced severe pain with twisting, pivoting, and standing, along with right groin pain; although the knee exam remained stable and imaging showed implants in good position, workup was initiated to rule out infection and iliopsoas tendinitis.Ultimately, she was referred to pain management for chronic, debilitating right hip pain and instability, significantly limiting safe ambulation despite multiple prior surgical interventions.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.This complaint is confirmed based on the provided 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: PSN REV FEM CMT CCR STD SZ 7R
• 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: 22072795
• Report Number: 0001822565-2025-01519
• Device Sequence Number: 8711801
• Product Code: JWH
• UDI-Device Identifier: 00889024562561
• UDI-Public: (01)00889024562561(17)300802(10)64838116
• 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): 09/18/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 42504606202
• Device Lot Number: 64838116
• 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: 09/09/2025
• Initial Report FDA Received Date: 05/22/2025
• Supplement Report FDA Received Date: 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2020
• 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.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 67 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White