MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. ALL POLY PATELLA STANDARD SIZE 32 MM; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problems Muscular Rigidity (1968); Loss of Range of Motion (2032); Ambulation Difficulties (2544); Limited Mobility Of The Implanted Joint (2671)

Event Date 08/18/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: item 00575201501 lot 64169588.Item 90597003010 lot 64198343.Item 00597206532 lot 64143810.Report source: foreign (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product remains 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: 0001822565-2021-00294, 0001822565-2021-00295.

Event Description

It was reported that approximately 1 year post a left tka, the patient underwent manipulation under anesthesia due to stiffness and difficulty ambulating.Attempts have been made and no further information has been provided.

Event Description

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

Manufacturer Narrative

(b)(4) this follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, b6, g4, g7, h1, h2, h3,h6, h10.This complaint was not confirmed as official medical records were not provided.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Joint assist records were provided and reviewed by a health care professional.Review found at 1 year visit patient had difficulty ambulating and stiffness.Patient had mua and was resolved.Further medical records were not provided.A definitive root cause cannot be determined.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 STANDARD SIZE 32 MM
• 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: 11266673
• MDR Text Key: 229864526
• Report Number: 0002648920-2021-00018
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00889024215146
• UDI-Public: (01)00889024215146(17)260831(10)64143810
• Combination Product (y/n): N
• PMA/PMN Number: K173057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 03/22/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00597206532
• Device Lot Number: 64143810
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/25/2021
• Initial Date FDA Received: 02/02/2021
• Supplement Dates Manufacturer Received: 03/16/2021
• Supplement Dates FDA Received: 03/22/2021
• 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
• Patient Age: 57 YR
• Patient Weight: 102