MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA STEM EXTENSION 6MM OFFSET SPLINED UNCEMENTED 15 MM DIA +135 MM; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problem Hematoma (1884)

Event Date 12/22/2020

Event Type  Injury  

Event Description

It was reported that thirteen days post-operation the patient experienced hemarthrosis and developed a large effusion.60ml of bloody synovial fluid was aspirated without complication.

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.Additional associated products & mdrs.42504606602 persona femur cemented standard right size 9 lot# 64797873.Mdr: 0001822565-2024-00940.42556806605 persona femoral posterior augment cemented size 9, 9+5mm lot# 64853512.Mdr: 0001822565-2024-00941.42560613517 persona stem extension 6mm offset splined uncemented 17mm dia 135mm lot# 64542502.Mdr: 0001822565-2024-00942.42542007902 persona tibia fixed cemented right size g stem lot# 64679182.Mdr: 0001822565-2024-00943.42545000510 persona tibial central cone size x-small lot# 64788568.Mdr: 0001822565-2024-00945.42522600912 persona articular surface fixed bearing cps rt 12 mm lot# 63282987.Mdr: 0001822565-2024-00946.00587806541 nexgen trabecular metal standard primary patella lot# 64245301.Mdr: 0001822565-2024-00947.Additional associated products heraeus palacos cement x 2 lot# 94174818.Heraeus palacos cement x 2 lot# 94164864.

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.Hemarthrosis is a condition of articular bleeding, that is into the joint cavity.This can occur after an injury or, more commonly, in bleeding disorders such as hemophilia.Patients will typically present with pain, swelling and a decreased range of motion of the involved joint.Joint effusion occurs when too much fluid builds up around a joint in your body.Treatment includes nonsteroidal anti-inflammatory drugs (nsaids), rest, ice, compression, and elevation.Healthcare provided may also recommend arthrocentesis, draining the synovial fluid from your joint.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 STEM EXTENSION 6MM OFFSET SPLINED UNCEMENTED 15 MM DIA +135 MM
• 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: 18922654
• MDR Text Key: 337885923
• Report Number: 0001822565-2024-00944
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00887868250293
• UDI-Public: (01)00887868250293(17)300729(10)64799579
• 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,Followup
• Report Date: 04/04/2024

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: 42560613515
• Device Lot Number: 64799579
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/22/2024
• Initial Date FDA Received: 03/18/2024
• Supplement Dates Manufacturer Received: 03/25/2024
• Supplement Dates FDA Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2020
• 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
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 90 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White