MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA STEM EXT 6MM OFFSET SPLINED UNCEMENTED 14MM DIA 135MM L; PROSTHESIS, KNEE

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Pain (1994)

Event Date 02/06/2021

Event Type  Injury  

Event Description

It was reported, a morbidly obese patient began to experience an increase in pain.And reports, taking a 'couple tumbles' approximately 8 months post implantation.Patient presented to the er at this time.During this visit, the patient reports running out of norco, as it was being taken more than prescribed for the pain.A ct scan was performed and displayed no abnormal findings.And the patient was sent home with over-the-counter nsaids and topical analgesics.All implants remain in place.And the patient has continued within the study without further complication to the study knee.

Manufacturer Narrative

(b)(4).Customer has indicated, that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products: -------------------------------------------- 42504607002, persona femur cemented std right size 11, lot#: 64532701; 42545001012, persona femoral central cone size medium, lot#: 64189936; 42556807005, persona femoral post augment cemented size 11, 11+5mm, lot#: 64485584; 42556607005, persona femoral dist augment cemented size 11, 11+5mm, lot#: 64664231; 42560113520, persona stem ext straight splined uncemented 20mm dia 135mm l, lot#: 64635804; 42542007902, persona tibia fixed cemented right size g, lot#: 64334603; 42545000513, persona tibial central cone size large, lot#: 64189641; 42522601012, persona articular surface fxd brg (cps) right 12 mm.

• Brand Name: PERSONA STEM EXT 6MM OFFSET SPLINED UNCEMENTED 14MM DIA 135MM L
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19119258
• MDR Text Key: 340340442
• Report Number: 0001822565-2024-01270
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00887868250286
• UDI-Public: (01)00887868250286(17)300531(10)64729231
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191625
• 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
• Report Date: 04/16/2024

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42560613514
• Device Lot Number: 64729231
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/26/2024
• Initial Date FDA Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/18/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization
• Patient Sex: Male
• Patient Weight: 171 KG