MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PSN FEM PS PPS CCR STD SZ9 L; PROSTHESIS, KNEE

Catalog Number	42-5066-066-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Scar Tissue (2060); Impaired Healing (2378); Fluid Discharge (2686); Muscle/Tendon Damage (4532); Swelling/ Edema (4577)
Date of Event	08/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: psn tib np 0 deg, #item 42536007501, #lot 66964507.Psn asf ps 10mm, #item 42512400710, #lot 66228986.Stryker simplex hv, #item un, #lot 443aa701kf.Therapy date: remain implanted.H6: component code mechanical (g04) - femur.Attempts have been made to gather all product identification information and no further information has been provided.An investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that a patient had an initial left total knee arthroplasty.Two months lather the knee was aspirated for mild wound drainage.Patient complained of pain, swelling, and wound healing issues.Three months after implantation mri showed a quad tendon defect with retinacular tear and extravasation of fluid from deep within the knee joint to superficial and left quadricep tendon repair with no explantation of components.During the surgical intervention, the joint was exposed and noted scar tissue that was excised with the quad tendon repair.The components remained implanted, 4 months later left knee prepatellar bursa aspiration for mild wound drainage.No results of aspirations provided.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4,b5,d2,g1,g3,g6,h1,h2,h3,h4,h6.The cmp was confirmed.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.Pn 42506606601 (psn ps standard pps femur) & pn 42536007501 (psn 0deg cemented keel tibia): review of complaint history found no additional related issues for these items and the reported part and lot combinations.Medical records provided and reviewed state that the patient underwent an initial left total knee arthroplasty (tka).The procedure was rosa-assisted, completed without intraoperative complications.2 months post implantation, the left knee was aspirated for mild wound drainage.On 3 months later, an mri demonstrated a quadriceps tendon defect with retinacular tear and extravasation of fluid.The patient underwent a left quadriceps tendon defect arthrotomy and repair with sutures.The patient had experienced wound healing issues, pain, and swelling, with multiple deep periprosthetic joint infection workups all returning negative results.Mri confirmed a retinacular defect, and the patient was indicated for left quadriceps tendon rupture repair with implants noted to be in good condition.The arthrotomy was found intact and scarred over with no extra-articular fluid present.Visualization and palpation, in conjunction with review of the preoperative mri, revealed scarring at the medial retinaculum that was thin with some joint effusion collection, and the decision was made to open the joint.A washout was performed with imbrication, excision of the scarred medial retinaculum, and reinforced closure of the quadriceps tendon.The quadriceps tendon repair was completed without complication, and all study implants were not touched and remained implanted throughout the procedure.Four months post implantation, at the three-month post-operative visit, the patient reported severe problems with adls, mild pain, dissatisfaction with the knee, and a total rom of 100°.X rays shows no abnormalities.The left knee prepatellar bursa was aspirated again for mild wound drainage.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.
Event or Problem Description
No further information is available at the time of this report.

• Brand Name: PSN FEM PS PPS CCR STD SZ9 L
• 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: 23759800
• Report Number: 0001822565-2025-04413
• Device Sequence Number: 18668278
• Product Code: JWH
• UDI-Device Identifier: 00889024631755
• UDI-Public: (01)00889024631755(17)330719(10)66045272
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K221479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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
• Report Date (Section B): 03/25/2026

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: Lay User/Patient
• Device Catalogue Number: 42-5066-066-01
• Device Lot Number: 66045272
• 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: 11/20/2025
• Supplement Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2023
• 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: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 89 KG
• Patient Race: White