MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. FEMORAL COMPONENT PRECOAT SIZE E LEFT; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Scar Tissue (2060)
Date of Event	10/28/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2020-00074 and 0001822565-2020-00860.Concomitant medical products: articular surface regular constraint size yellow/c-h 10 mm height catalog#: 90597003010 lot#: 63205998, all poly patella standard size 32 mm diameter 8.5 mm thickness cemented catalog#: 00597206532 lot#: 63386486, tibial component pegged precoat for cemented use only size 3 catalog#: 00597003501 lot#: 63187291.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 or Problem Description
It was reported that patient underwent an initial left knee arthroplasty.Subsequently, approximately three months later, the patient underwent manipulation under anesthesia due to stiffness and limited range of motion.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records.Medical records state "left knee manipulation under anesthesia due to flexion contracture/arthrofibrosis.Manipulation under anaesthesia was performed on (b)(6) 2016 without complication, intraop flexion to 120 degrees, "still a bit short of full extension¿would set her up with outpatient therapy."" device history record was reviewed and no discrepancies were found.Root cause was unable to be determined.A summary of the investigation will be sent to the complainant.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: FEMORAL COMPONENT PRECOAT SIZE E LEFT
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• MDR Report Key: 9811569
• Report Number: 3007963827-2020-00074
• Device Sequence Number: 2807407
• Product Code: MBH
• UDI-Device Identifier: 00889024191198
• UDI-Public: (01)00889024191198(17)260430(10)63359667
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K071107
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2026
• Device Model Number: N/A
• Device Catalogue Number: 00575001501
• Device Lot Number: 63359667
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/24/2020
• Supplement Date Received by Manufacturer: 05/11/2020
• Initial Report FDA Received Date: 03/10/2020
• Supplement Report FDA Received Date: 05/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 83