MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMUR TRABECULAR METAL CRUCIATE RETAINING NARROW POROUS; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	08/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient underwent a knee revision approximately one year, ten months post implantation for pain and femoral loosening.Femoral implant and articular surface were revised.Tibial implant, tibial stem and patella were retained.No addtional information was made available.
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 discarded 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 --- 42522100810 articular surface medial congruent (mc) right 10 mm lot# 65048443 mdr: 3007963827-2023-00247 additional associated products --- 42532007102 tibia cemented 5 degree stemmed rt size e lot# 64760719 42557000114 stem extension tapered cemented 14mm dia 30mm l lot# 64964596 42540200035 all-poly patella cemented 35 mm diameter.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4, b5, d2, g1, g3, g6, h1, h2, h3, h6, h10   h6-component code- suggested code: mechanical (g04) - femur visual examination of the provided pictures identified the implants with foreign material on them.As the implants were not returned no additional evaluations could be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.The reported products were reviewed for compatibility with no issues noted.Review of complaint history found no additional related issues for this item [item (b)(4)] and the reported part and lot combination.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: initial operative report was reviewed with no complications noted.No revision operative notes/report were provided.Radiographs were provided and reviewed by a health care professional.The radiographs were not sent for further review as they are dated post-revision and would not enhance the investigation.Complaint is not 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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: FEMUR TRABECULAR METAL CRUCIATE RETAINING NARROW POROUS
• 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: 17765065
• Report Number: 0001822565-2023-02544
• Device Sequence Number: 6654224
• Product Code: JWH
• UDI-Device Identifier: 00889024470101
• UDI-Public: (01)00889024470101(17)310513(10)64947320
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K172524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2024

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: 42502206402
• Device Lot Number: 64947320
• 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: 08/28/2023
• Supplement Date Received by Manufacturer: 01/04/2024
• Initial Report FDA Received Date: 09/18/2023
• Supplement Report FDA Received Date: 01/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2021
• 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: Required Intervention; Hospitalization
• Patient Sex: Female