MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA ARTICULAR SURFACE FIXED BEARING POSTERIOR STABILIZED (PS); PROSTHESIS, KNEE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Muscular Rigidity (1968); Pain (1994); Limited Mobility Of The Implanted Joint (2671)

Event Date 09/24/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical device: persona femur cemented posterior stabilized (ps), catalog #: 42500607002, lot #: 64121962.Nexgen all poly patella, catalog #: 00597206638, lot #: 64163556.Tibia cemented 5 degree stemmed right size g, catalog #: 42532007902, lot #: 64281805.Cemented persona/ve surf & instruments, catalog #: 9800674105, lot #: unknown.Patella reamer blade with pilot hole 51 mm diameter single use only, catalog #: 00597909551, lot #: 64418785.Customer has indicated that the product will not be returned because it remains implanted.Reported event was unable to be confirmed due to limited information received from the customer.Device was not returned.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.  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.The event was initially reported on 0001822565-2019-04931.Multiple mdr: 3007963827-2020-00076, 0001822565-2019-04932.

Event Description

It was reported that the patient underwent a knee arthroplasty.Subsequently, the patient alleges experiencing pain, stiffness and limited range of motion in knee.Further, the patient alleges uses a cane to ambulate and is scheduled to undergo a manipulation procedure.No revision procedure has been reported to date.Attempt for further information has been made, but no further information has been provided.

• Brand Name: PERSONA ARTICULAR SURFACE FIXED BEARING POSTERIOR STABILIZED (PS)
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer (Section G): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 9825963
• MDR Text Key: 186529204
• Report Number: 3007963827-2020-00075
• Device Sequence Number: 1
• Product Code: OIY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 42522401012
• Device Lot Number: 64363148
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2019
• 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
• Patient Outcome(s): Required Intervention
• Patient Weight: 91