MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA TIBIA CEMENTED 5 DEGREE STEMMED; PROSTHESIS KNEE

Model Number N/A

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

Patient Problem Wound Dehiscence (1154)

Event Date 03/24/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: persona femur cemented posterior stabilized (ps) ,catalog # 42500605801, lot # unknown; persona articular surface fixed bearing posterior stabilized (ps) ,catalog # 42511400411, lot # unknown, catalog # lot # unknown.Customer has indicated that the product will not be returned because it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filled for this event: 3007963827-2021-00202, 0002648920-2021-00279.Remains implanted.

Event Description

It was reported patient had fall five weeks post implantation due to unknown reasons resulting in surgical wound dehiscence.Attempt for further information has been made, but no further information has been provided.

Manufacturer Narrative

Reported event was confirmed by review of medical records provided.Device was not returned.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.A definitive root cause cannot be determined.X-ray review indicates 1 month moderate pain/problems, pain 6/10 and dissatisfied with joint during activity, patient expresses dissatisfaction with postop exercises provided.Ae fall on operative knee, reopening of surgical wound, incision and drainage deep abscess bursa/hematoma thigh/knee region - no dictation/confirmation of abscess/hematoma in operative report.Operative report.Pdf 'dehisced her left knee after a fall in the clinic', wound irrigated and debrided without complication, very minimal dictation / no dictation of tissue assessment or depth of injury.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 Description

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

• Brand Name: PERSONA TIBIA CEMENTED 5 DEGREE STEMMED
• Type of Device: PROSTHESIS KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12525451
• MDR Text Key: 273091122
• Report Number: 0001822565-2021-02704
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172524
• 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: 11/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2021
• 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: 42532006401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other
• Patient Sex: Female
• Patient Weight: 119 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White