MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. ALL POLY PATELLA CEMENTED 35 MM DIAMETER; PROSTHESIS, KNEE

Model Number N/A

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

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

Event Date 05/06/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant associated products : item#:42522100710; articular surface medial congruent (mc) right 10 mm ;lot#:64349803.Item#:42502806202; femur trabecular metal cruciate retaining (cr) standard porous lot#:64065171.Item#:42530007102; natural tibia trabecular metal two-peg porous fixed bearing right size e;lot#:64405827.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it is still implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 3007963827 - 2020 - 00184, 0001822565 - 2020 - 02729.

Event Description

It was reported a patient had a right unilateral tka, and the patient experienced lysis of adhesions, limited rom, and pain and underwent a mua approximately six months later.

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.The following sections were updated: b4; b5; g4; g7; h1; h2; h3; h6.Reported event was confirmed by review of medical records.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: no complication during the surgery.On (b)(6) 2020, patient underwent arthroscopy for arthrofibrosis and mua on (b)(6) 2020.On (b)(6) 2020, patient experienced pain, limited extension and flexion along with ambulating with antalgic gait.Scar tissue was overgrown patella button inferiorly and medially.Patient continue to experience stiffness.A definitive root cause cannot be determined.Per package insert, pain, poor range of motion are known adverse effect of the system.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: ALL POLY PATELLA CEMENTED 35 MM DIAMETER
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• MDR Report Key: 10344441
• MDR Text Key: 201660415
• Report Number: 0002648920-2020-00359
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00889024230767
• UDI-Public: (01)00889024230767
• Combination Product (y/n): N
• PMA/PMN Number: K172524
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2020
• 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: 42540000035
• Device Lot Number: 64441717
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention