MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA PARTIAL KNEE CEMENTED FEMORAL COMPONENT SIZE 1 LEFT MEDIAL; PROSTHESIS, KNEE

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273)

Patient Problems Fall (1848); Pain (1994); Ambulation Difficulties (2544); Joint Laxity (4526)

Event Date 10/12/2021

Event Type  Injury  

Event Description

It was reported that the patient underwent a left unicompartmental knee arthroplasty revision to address medial collateral ligament sprain, continued pain and ligament instability following a fall approximately nine (9) months post-operatively.Initial operative notes noted no intraoperative complications.Revision operative notes noted the patient had worsening pain, increasing functional limitations and there was a concern for ligamentous instability.No intraoperative complications were noted.Attempts have been made; however, no additional information is available.

Manufacturer Narrative

(b)(4).D10 - concomitant devices - unknown persona partial knee femur size 1 catalog #: ni lot #: ni.Unknown persona partial knee vivacit-e polyethylene articular surface 10mm catalog #: ni lot #: ni, unknown persona partial knee tibial tray size c catalog #: ni lot #: ni, unknown bone cement catalog #: ni lot #: ni.The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the device was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this patient; please see all reports associated with this event: 0001825034-2023-02240 h3 other text : investigation incomplete.

Manufacturer Narrative

This follow-up report is being filed to relay additional information.D10 - concomitant devices - persona partial knee articular surface left medial size c 10mm catalog #: 42518200310.Lot #: 64157519, persona partial knee cemented tibial component size c left medial.Catalog #: 42538000301.Lot #: 64468722, biomet bone cement r 1x40.Catalog #: 110035368.Lot #: 004aac2502.

Event Description

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

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.H6 - component code - proposed code is mechanical (g04) - femur.Medical records provided were reviewed and the reported event was confirmed.The device history records were reviewed and no discrepancies were identified.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.

• Brand Name: PERSONA PARTIAL KNEE CEMENTED FEMORAL COMPONENT SIZE 1 LEFT MEDIAL
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17808649
• MDR Text Key: 324151353
• Report Number: 0001825034-2023-02239
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 00880304808447
• UDI-Public: (01)00880304808447(17)290731(10)64386211
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42558000101
• Device Lot Number: 64386211
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2019
• 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 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Weight: 118 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White