MAUDE Adverse Event Report: . PERSONA TIBIA CEMENTED 5 DEGREE STEMMED RIGHT SIZE G; PROSTHESIS, KNEE

Model Number N/A

Device Problem Positioning Problem (3009)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/22/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant devices -tibia cemented 5 degree stemmed right size g catalog # 42532007902 lot #: 64831313, articular surface fixed bearing ultracongruent (uc) right 14 mm height catalog # 42522200614 lot #: 63722485; unknown instrument catalog # n/i lot #: n/i.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.Multiple mdr reports were filed for this patient; please see all reports associated with this event: 3007963827 - 2021 - 00244 and 0001822565 - 2021 - 03056.

Event Description

It was reported that after the tibia and femur were cemented, the surgeon felt that there was an issue with the anterior portion of the tibia where the poly insertion instrument engages for final poly insertion.The instrument would not engage correctly and the poly wouldn't seat.Attempts have been made and no further information has been provided.

Manufacturer Narrative

Upon receiving additional information of the reported event, it was determined to be not reportable.Follow up confirms that there are no issue with this device.The initial report should be voided.

Event Description

Upon receiving additional information of the reported event, it was determined to be not reportable.Follow up confirms that there are no issue with this device.The initial report should be voided.

• Brand Name: PERSONA TIBIA CEMENTED 5 DEGREE STEMMED RIGHT SIZE G
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): .; 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: 12669563
• MDR Text Key: 278114951
• Report Number: 3007963827-2021-00245
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00889024471108
• UDI-Public: (01)00889024471108(17)301109(10)64831313
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122765
• 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: 01/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42532007902
• Device Lot Number: 64831313
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/31/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/19/2020
• 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
• Patient Sex: Male
• Patient Weight: 78 KG