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
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Joint effusion (4849)
Date of Event	12/22/2020
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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 or Problem Description
No further event information available at the time of this report.
Additional 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
• Common Device Name: 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
• Report Number: 0001822565-2024-00944
• Device Sequence Number: 7505640
• Product Code: JWH
• UDI-Device Identifier: 00887868250293
• UDI-Public: (01)00887868250293(17)300729(10)64799579
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K191625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2024
• Supplement Date Received by Manufacturer: 03/25/2024
• Initial Report FDA Received Date: 03/18/2024
• Supplement Report FDA Received Date: 04/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2020
• 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 Sex: Male
• Patient Weight: 90 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White