MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. ARTICULAR SURFACE FIXED BEARING CRUCIATE RETAINING (CR) RIGHT 10 MM HEIGHT; 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); Limited Mobility Of The Implanted Joint (2671)

Event Date 12/10/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated report: 3007963827-2021-00022.Medical product: femur cemented cruciate retaining (cr) standard right size 5, item# 42502605802, lot# 64587123.Tibia cemented 5 degree stemmed right size c, item# 42532006402, lot# 63783332.Report source - (b)(6).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 that a patient underwent a right total knee arthroplasty and, subsequently, the patient underwent a manipulation under anesthesia due to stiffness.The stiffness was noted as resolved the same day without further complication.There is no additional information at this time.

Event Description

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

Manufacturer Narrative

This follow-up is being submitted to relay additional information.No product was returned or pictures provided; therefore, visual and dimensional evaluations could not be performed.Medical records and radiographs were provided and reviewed by a health care professional.Radiographs were not reviewed as images would not enhance the investigation process as adhesions and scar tissue are not visible via x-ray images.Review of the available records identified the following: initial surgery: pre op rom 12-130 degrees, no patellar resurfacing, no intra op complications noted, or time 63 minutes; (approximately two months¿ post implantation) stiff knee resulting in manipulation, resolved same day; three month follow-up: moderate pain, moderate difficulties, rom 30-100 degrees, some problems with activities, health score 69.Device history record (dhr) was reviewed for deviations and/ or anomalies with no deviations / anomalies identified.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: ARTICULAR SURFACE FIXED BEARING CRUCIATE RETAINING (CR) RIGHT 10 MM HEIGHT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• MDR Report Key: 11273129
• MDR Text Key: 230068049
• Report Number: 3007963827-2021-00023
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00889024239623
• UDI-Public: (01)00889024239623(17)250228(10)63603317
• Combination Product (y/n): N
• PMA/PMN Number: K113369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/15/2021

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: 42521000410
• Device Lot Number: 63603317
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/25/2021
• Initial Date FDA Received: 02/03/2021
• Supplement Dates Manufacturer Received: 03/12/2021
• Supplement Dates FDA Received: 03/15/2021
• 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 Age: 53 YR
• Patient Weight: 65