MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. ARTICULAR SURFACE FIXED BEARING CRUCIATE RETAINING (CR) LEFT 10 MM HEIGHT; 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); Swelling (2091)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2020-00119 and 0002648920-2020-00234.Event date: unknown date in (b)(6) 2019.Therapy date: unknown date in (b)(6) 2019.Concomitant medical products: femur cemented cruciate retaining (cr) narrow left size 6 catalog#: 42502006001 lot#: 63878209, tibia cemented 5 degree stemmed left size d catalog#: 42532006701 lot#: 63727672.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 left total knee arthroplasty.Subsequently, 6 months post operatively, a tendon started catching on her implants and caused swelling.Patient underwent additional physical therapy and the knee locked at a 90 degree angle.Patient underwent manipulation under anesthesia where the surgeon also cut out scar tissue.
Additional Manufacturer Narrative
This follow-up report is being filed to relay this report is a duplicate of 0002648920-2020-00235.
Event or Problem Description
This follow-up report is being filed to relay this report is a duplicate of 0002648920-2020-00235.

• Brand Name: ARTICULAR SURFACE FIXED BEARING CRUCIATE RETAINING (CR) LEFT 10 MM HEIGHT
• Common Device Name: 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: 9988264
• Report Number: 0002648920-2020-00234
• Device Sequence Number: 3700623
• Product Code: MBH
• UDI-Device Identifier: 00889024229891
• UDI-Public: (01)00889024229891(17)200930(10)63128799
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K121771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2020

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: 09/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 42512000410
• Device Lot Number: 63128799
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/30/2020
• Supplement Date Received by Manufacturer: 06/02/2020
• Initial Report FDA Received Date: 04/22/2020
• Supplement Report FDA Received Date: 06/05/2020
• 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: 61