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

Model Number	N/A
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870); Failure of Implant (1924); Osteopenia/ Osteoporosis (2651); Muscle/Tendon Damage (4532)
Date of Event	04/21/2023
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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 or Problem Description
No further event information available at the time of this report.

• Brand Name: PERSONA CEMENTED STEMMED TIBIAL COMPONENT LEFT SIZE D
• Common Device Name: 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
• Report Number: 3007963827-2023-00128
• Device Sequence Number: 5238548
• Product Code: JWH
• UDI-Device Identifier: 00889024471030
• UDI-Public: (01)00889024471030(17)320520(10)65363340
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K122765
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2023

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: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2023
• Supplement Date Received by Manufacturer: 09/01/2023
• Initial Report FDA Received Date: 05/19/2023
• Supplement Report FDA Received Date: 09/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 83 KG