MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA CEMENTED STEMMED TIBIAL COMPONENT LEFT SIZE D; PROSTHESIS, KNEE

Model Number N/A

Device Problem Unstable (1667)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Failure of Implant (1924); Osteopenia/ Osteoporosis (2651); Muscle/Tendon Damage (4532)

Event Date 04/21/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10 - concomitant devices - persona cruciate retaining articular surface left 10mm, unknown persona femoral component catalog #: ni lot #: ni.G2 - report source - foreign: event occurred in australia.The complainant has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.H3 other text : investigation incomplete.

Event Description

It was reported that the patient underwent a left knee arthroplasty revision twenty (20) days post-operatively to address a periprosthetic fracture with an unstable displaced tibial implant after a fall.During the procedure, soft tibial bone and a medial retinaculum tear with an intact patella tendon attached to the tuberosity fracture were also identified.A mesh plate was used to reduce the fracture and the tibial components were replaced and a stem extension and large central cone were added.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Medical records provided confirmed that the patient fell and sustained a periprothetic fractured with an unstable displaced tibial implant.The device history records were reviewed and no discrepancies were identified.It was noted that the patient's condition could have contributed to the reported fall, however, a definitive root cause could not be determined 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 Description

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

• Brand Name: PERSONA CEMENTED STEMMED TIBIAL COMPONENT LEFT SIZE D
• 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: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16966578
• MDR Text Key: 315640159
• Report Number: 3007963827-2023-00128
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00889024471030
• UDI-Public: (01)00889024471030(17)320520(10)65363340
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K122765
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2023
• 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: 42532006701
• Device Lot Number: 65363340
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2022
• 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 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 83 KG