MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. ALL POLY PATELLA STANDARD SIZE 29 MM DIAMETER 8.0 MM THICKNESS CEMENTED; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.X-rays and medical records were provided and reviewed by a healthcare professional.No findings available from medical records due to lack of records provided.X-ray review found radiolucency at the bone-metal interface of the femoral implant.Bone quality is osteopenic.A definitive root cause could not be established with the information provided.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 event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was requested but not returned by the hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: 00575201506, cruciate retaining cr-flex gender solutions female femoral component, lot # 63058383.00588604510, trabecular metalac cruciate retaining monoblock tibial component, lot # 63705140.Foreign report source: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 00901.3005751028 - 2020 - 00016.
Event or Problem Description
It was reported that approximately 7 months post implantation, the patient developed an infection of the right knee arthroplasty.The patient underwent a washout of the knee.Subsequently, the patient has now been revised of the knee implants approximately 15 months post initial implantation due to septic loosening.Attempts have been made and no further information has been provided.

• Brand Name: ALL POLY PATELLA STANDARD SIZE 29 MM DIAMETER 8.0 MM THICKNESS CEMENTED
• 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
• MDR Report Key: 9824000
• Report Number: 0002648920-2020-00169
• Device Sequence Number: 16911309
• Product Code: JWH
• UDI-Device Identifier: 00889024215139
• UDI-Public: (01)00889024215139
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2020

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: 07/31/2026
• Device Model Number: N/A
• Device Catalogue Number: 00597206529
• Device Lot Number: 64129660
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/20/2020
• Supplement Date Received by Manufacturer: 05/08/2020
• Initial Report FDA Received Date: 03/12/2020
• Supplement Report FDA Received Date: 05/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 79