MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. ARTICULAR SURFACE MEDIAL CONGRUENT (MC) LEFT 10 MM HEIGHT; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problems Adhesion(s) (1695); Loss of Range of Motion (2032)

Event Date 04/29/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2020-00085, 3007963827-2020-00086, and 0002648920-2020-00179.Concomitant medical products: femur cemented cruciate retaining (cr) narrow left size 6 catalog#: 42502006001 lot#: 64116798, all poly patella cemented 32 mm diameter catalog#: 42540000032 lot#: 64181002, natural tibia trabecular metal two-peg porous fixed bearing left size d catalog#: 42530006701 lot#: 64050819.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 patient underwent a left total knee arthroplasty.Subsequently, she had a closed manipulation at approximately 4 weeks postop and a closed manipulation under anesthesia (mua) approximately three months later, with hospital admission for aggressive pt and continuous cmp due to ongoing postoperative arthrofibrosis and limited rom.The outcome remains pending.

Manufacturer Narrative

This follow-up is being submitted to relay additional information.Updated: b4, b5, d4, g4, g7, h1, h2, h3, h6, and h10.No product was returned or pictures provided; therefore, visual and dimensional evaluations could not be performed.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: at six-month post op patient had flexion 94/extension 6 and underwent closed manipulation.Radiographs show no evidence of gaps between bone/ implant interface.Approximately four months¿ post op patient had range of motion from 12-56 and underwent mua.Device history record (dhr) was reviewed for deviations and/ or anomalies with no related 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.

Event Description

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

• Brand Name: ARTICULAR SURFACE MEDIAL CONGRUENT (MC) LEFT 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: 9842117
• MDR Text Key: 183725303
• Report Number: 3007963827-2020-00086
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: K150090
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup
• Report Date: 06/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 42512100410
• Device Lot Number: 64164251
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/09/2020
• 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
• Patient Weight: 54