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 Codes	Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Swelling (2091); No Information (3190)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Event date: unknown date in (b)(6) 2019.Explant date: unknown date in (b)(6) 2019.Therapy date: unknown date in (b)(6) 2019.Medical devices: tibia cemented 5 degree stemmed left size d catalog#: 42532006701, lot#: 63727672, femur cemented cruciate retaining (cr) narrow left size 6 catalog#: 42502006001, lot#: 63878209.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as its location is unknown.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 a left total knee arthroplasty.Approximately six months later, following more conservative approaches to address instability, the tendon was released and the tibial insert was replaced with a more stabilizing version.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Medical records were not provided.However, information obtained from the phone conversation stated six months after initial procedure patient¿s tendon started catching on her implants (pa told her it was tendon) and swelling.She had extra pt and knee locked at 90-degree angle.The patient had manipulation and cleaned up scar tissue (big blob) but still had catching and day after manipulation the tendon caught again and they went in and released the tendon and replaced the bearing with a more stabilizing one.Device history record was reviewed and no discrepancies were found.Root cause was unable to 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 or Problem Description
It was reported that patient is experiencing swelling, catching, loss of range of motion, and pain approximately 6 months after the initial procedure.The patient underwent one manipulation under anesthesia with removal of scar tissue on an unknown date.The next day, the patient reports that she underwent a second manipulation with scar tissue removal, tendon release, and poly swap due to continued instability and tendon catching.During the revision, a bent tibial screw was noted, and a revision procedure of all components was planned.

• 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: 9988283
• Report Number: 0002648920-2020-00235
• Device Sequence Number: 3700624
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2020

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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 61