MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. ALL POLY PATELLA CEMENTED 29 MM DIAMETER; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Loss of Range of Motion (2032); Swelling/ Edema (4577)
Date of Event	12/05/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient has an initial left total knee arthroplasty.Subsequently, patient had a manipulation under anesthesia on an unknown date due to arthrofibrosis, stiffness, pain, and decreased rom.Patient now reports swelling since arthroscopy.Subsequently 1st stage revision due to suspected infection.During the procedure noted scar tissue and erosive changes to the medial tibia.All components and cement removed.Nail and antibiotic cement implanted without complications.
Additional Manufacturer Narrative
(b)(4).During the investigation process a review of the sterile certifications were not reviewed, as no product part/lot information was provided.All devices manufactured follow acceptable sterilization processes according to published iso/aami/astm & eu guidelines.There are multiple factors that may contribute to an infection that are outside the control of zimmer biomet, such as external factors, i.E.Hospital/surgical environment, provider related risk factors, and/or patient comorbidities/risk factors.All products manufactured follow appropriate standards, and the reported infection occurred > 90 days; therefore, implanted products are not identified as the source or contributing to the reported infection.Additional associated products & mdrs: 42502605801 femur cemented cruciate retaining (cr) std lt iz 5 lot# 63784658, mdr: 3007963827-2023-00046.42532006701 tibia cemented 5 degree stemmed lt sz d lot# 63987513, mdr: 3007963827-2023-00047.42511200413 articular surface fixed bearing ultracongruent lt 13mm lot# 62638083, mdr: 0002648920-2023-00044.42557000114 stem extension tapered cemented 14mm dia +30 mm lot# unk, mdr: 0001822565-2023-00637.Additional associated products: unk competitor bone cement.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: ALL POLY PATELLA CEMENTED 29 MM DIAMETER
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16521255
• Report Number: 0002648920-2023-00045
• Device Sequence Number: 6573286
• Product Code: JWH
• UDI-Device Identifier: 00889024643697
• UDI-Public: (01)00889024643697(17)260531(10)64063564
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K172524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/09/2023

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: 05/31/2026
• Device Model Number: N/A
• Device Catalogue Number: 42540000029
• Device Lot Number: 64063564
• 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: 02/16/2023
• Initial Report FDA Received Date: 03/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2018
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 102 KG