MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIAL AUGMENT CEMENTED HALF BLOCK LEFT MEDIAL SIZE EF 5 MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient underwent a knee revision procedure.Subsequently, the patient was revised on 2 years later due to significant bone loss and poor fixation with cement and aseptic loosening.
Additional Manufacturer Narrative
(b)(4).G2: australia.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was requested but not returned by the facility.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products & mdrs: 42557000114 stem extension tapered cemented 14mm dia +30mm lot# 65264198, mdr: 0001822565-2023-01024; 42542007101 tibia fixed cemented left size e lot# 64716421, mdr: 0001822565-2023-01025; 42555805105 tibial augment cemented half block left medial size ef 5mm lot# 64982113, mdr: 0001822565-2023-01026.Additional associated products: 42512100712 articular surface medial congruent left 12mm lot# 64807641; knee-unk-persona patella ; knee-unk-persona femur; unk bone cement.
Event or Problem Description
It was reported the patient underwent a knee revision procedure.Subsequently, the patient was revised one year later due to significant bone loss and poor fixation with cement and aseptic loosening.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.  visual examination of the provided pictures identified a tibial implant that has been removed from a patient with foreign material attached.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.The reported products were reviewed for compatibility with no issues noted.Medical records were not provided.Radiographs were provided, however they are undated and a timeline to correspond to the allegations cannot be established.The revision surgery was confirmed by the images provided, however the loosening that was claimed could not be confirmed.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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: TIBIAL AUGMENT CEMENTED HALF BLOCK LEFT MEDIAL SIZE EF 5 MM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16743136
• Report Number: 0001822565-2023-01027
• Device Sequence Number: 15135152
• Product Code: JWH
• UDI-Device Identifier: 00889024557185
• UDI-Public: (01)00889024557185(17)301205(10)64925183
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K191625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2023

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: 42555805305
• Device Lot Number: 64925183
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2023
• Supplement Date Received by Manufacturer: 07/25/2023
• Initial Report FDA Received Date: 04/14/2023
• Supplement Report FDA Received Date: 08/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female