MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. FEMUR CEMENTED CRUCIATE RETAINING (CR) NARROW LEFT SIZE 11; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported patient underwent an initial knee arthroplasty.Patient underwent a revision two years and two months post procedure.Scan showed loosening of femoral component.When revised, it appears no cement has bonded to the femoral component.Only femoral component was revised.Tibial was well fixed.
Additional Manufacturer Narrative
(b)(4) g2: australia.H6-component code- suggested code: mechanical (04) - femur.Visual examination of the returned product found it to exhibit signs of being implanted wear/discoloration.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.The reported products were reviewed for compatibility with no issues noted.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Medical records were not provided.This complaint could not be confirmed.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.Additional associated products: 42540200032  all-poly patella cemented 32 mm diameter lot# 64776030, 42532007101 natural tibia cemented 5 degree stemmed left size e lot# 64659263, 42512000510  articular surface fixed bearing (cr) left 10 mm lot# 64528761, unk bone cement.

• Brand Name: FEMUR CEMENTED CRUCIATE RETAINING (CR) NARROW LEFT SIZE 11
• 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: 16955429
• Report Number: 0002648920-2023-00096
• Device Sequence Number: 7041140
• Product Code: JWH
• UDI-Device Identifier: 00889024229990
• UDI-Public: (01)00889024229990(17)280331(10)63938217
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K113369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/17/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42502007001
• Device Lot Number: 63938217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2023
• 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: 12/12/2022
• Initial Report FDA Received Date: 05/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2018
• 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