MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. ALL POLY PATELLA CEMENTED 38 MM DIAMETER; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problems Adhesion(s) (1695); Pain (1994); Loss of Range of Motion (2032); Limited Mobility Of The Implanted Joint (2671)

Event Date 06/17/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2021-00324, 3007963827-2021-00026.Concomitant medical devices: femur trabecular metal cruciate retaining (cr) standard porous catalog#: 42502807002 lot#: 64592481.Articular surface medial congruent (mc) right 10 mm height catalog#:42522100910 lot#: 64453825.Natural tibia trabecular metal two-peg porous fixed bearing right size h catalog#: 42530008302 lot#: 64297605.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the patient underwent a right knee arthroscopy for lysis of adhesions approximately three months post-implantation dud to pain, limited mobility, stiffness, and adhesions.The patient continues to report pain and stiffness.Outcome is pending.

Event Description

It was reported the patient underwent a right knee arthroscopy for lysis of adhesions approximately three months post-implantation dud to pain, limited mobility, stiffness, and adhesions.The patient continues to report pain and stiffness.The site reports the outcome has since resolved.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Updated: b4, b5, g3, g6, h2, h3, h6, and h10.Reported event was unable to be confirmed due to limited information received from the customer.Medical records were provided and reviewed by a health care professional via mymoblity.Review of the available records identified the following: patient experience moderate pain for almost a year after ops along with stiffness and arthrofibrosis.The patient had rom 6-105 after 3 months of post-ops.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.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: ALL POLY PATELLA CEMENTED 38 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: 11285799
• MDR Text Key: 230478815
• Report Number: 0002648920-2021-00023
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00889024247659
• UDI-Public: (01)00889024247659(17)270930(10)64545012
• 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: 04/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42540000038
• Device Lot Number: 64545012
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 108