MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMUR CEMENTED POSTERIOR STABILIZED (PS) STANDARD LEFT SIZE 8; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Udi #: (b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product is not available due to hospital policy.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent a total knee arthroplasty on (b)(6) 2018.Subsequently, the patient's femoral device was revised on (b)(6) 2020 due to pain.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No devices or photos were received; therefore, the condition of the components is unknown.Review of the device history records for identified no deviations or anomalies during manufacturing.Insufficient information provided.Unable to perform a compatibility check.Review of complaint history for part# 42500606401, lot # 63945439 found no additional related issues for this item and the reported part and lot combination.Medical records were not provided.Undated and unlabeled x-rays were provided.X-ray review by mmi states that there is anatomic alignment of implants.There was lucency noted along tibial and femoral components.Root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.This complaint is not confirmed.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: FEMUR CEMENTED POSTERIOR STABILIZED (PS) STANDARD LEFT SIZE 8
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10698317
• Report Number: 0001822565-2020-03577
• Device Sequence Number: 3281851
• Product Code: JWH
• UDI-Device Identifier: 00889024229235
• UDI-Public: (01)00889024229235
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K113369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2020

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 Model Number: N/A
• Device Catalogue Number: 42500606401
• Device Lot Number: 63945439
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/28/2020
• Supplement Date Received by Manufacturer: 12/02/2020
• Initial Report FDA Received Date: 10/19/2020
• Supplement Report FDA Received Date: 12/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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 Weight: 103