MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. NATURAL TIBIA CEMENTED 5 DEGREE STEMMED LEFT SIZE E; PROSTHESIS, KNEE

Model Number N/A

Device Problem Unintended Movement (3026)

Patient Problems Adhesion(s) (1695); Scar Tissue (2060)

Event Date 11/04/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2022-00068, 3007963827-2022-00069.Medical devices: femur cemented cruciate retaining (cr) standard left size 7 catalog#: 42502606201 lot#: 64343711.Articular surface medial congruent (mc) left 11 mm height catalog#: 42512100711 lot#: 64419136.All-poly patella cemented 35 mm diameter catalog#: 42540200035 lot#: 64621968.Biomet bc r 1x40 us catalog#: 110035368 lot#: 915cak19.Biomet bc r 1x40 us catalog#: 110035368 lot#: 915cak19.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported the patient underwent a left knee revision approximately eight months post-implantation due to arthrofibrosis and implant malposition.Attempts to obtain additional information have been made; however, no more is available.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Proposed component code: mechanical (g04) - stem.Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not 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.

• Brand Name: NATURAL TIBIA CEMENTED 5 DEGREE STEMMED LEFT SIZE E
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer (Section G): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13721117
• MDR Text Key: 286941650
• Report Number: 3007963827-2022-00070
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00889024471054
• UDI-Public: (01)00889024471054(17)291130(10)64475243
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172524
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42532007101
• Device Lot Number: 64475243
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 93 KG