MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOMET CC CRUCIATE TRAY 75MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Noise, Audible (3273); Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Limited Mobility Of The Implanted Joint (2671)
Date of Event	07/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Two tibial tray product identifications were reported in conjunction with this event.It is unknown after follow-up attempts which device was revised.The information for the second liner is as follows: item name: biomet cc cruciate tray 75mm, catalog number: 141234, lot number: j6099844, expiration date: jul 14, 2027, manufacture date: aug 18, 2017.Concomitant medical products: e1 vngd cr tib brg 71/75x12, item# ep-183442, lot# 583010.E1 vngd as tib brg 14x75, item# ep-189084, lot# 348630.Report source - (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation as it has been discarded.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 a patient was revised approximately four months¿ post implantation due to abnormal knee joint noise, limited knee joint movement, and pain.When the patient returned to the hospital and was examined, it was discovered that the locking bar was slack and had backed out.Three months after the operation, the knee joint was normal.There is no additional information at this time.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.The reported event was confirmed through medical records.Medical records and radiographs were provided and reviewed by a healthcare professional.Provided radiographs show the locking bar displaced medially and extending into the soft tissue.Medical records for the revision surgery note the joint prosthesis and poly are stable with no loosening or wear.Locking bar was replaced with no complications.No product was returned or pictures provided; therefore, visual and dimensional evaluations could not be performed.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.

• Brand Name: BIOMET CC CRUCIATE TRAY 75MM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9385200
• Report Number: 0001825034-2019-05360
• Device Sequence Number: 2450559
• Product Code: JWH
• UDI-Device Identifier: 00880304008328
• UDI-Public: (01)00880304008328
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K171054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2019

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 Model Number: N/A
• Device Catalogue Number: 141234
• Device Lot Number: J6098469
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/05/2019
• Supplement Date Received by Manufacturer: 12/13/2019
• Initial Report FDA Received Date: 11/27/2019
• Supplement Report FDA Received Date: 12/17/2019
• 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 Age: 79 YR