MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIA FIXED NON-POROUS RIGHT SIZE D STEM EXTENSION USE REQUIRED; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).(b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product remain implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2021-00326.
Event or Problem Description
It was reported that during a revision procedure the surgeon confirmed that the stem dropped from the tibia component by x-rays during the operation.The operation ended without revision at the surgeon's discretion.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4) this complaint was confirmed.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.X-rays were provided and reviewed by a health care professional.Review found a wide gap between the proximal component of the tibial hardware and the tibial stem which have been separated.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: TIBIA FIXED NON-POROUS RIGHT SIZE D STEM EXTENSION USE REQUIRED
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11282956
• Report Number: 0001822565-2021-00325
• Device Sequence Number: 3543812
• Product Code: MBH
• UDI-Device Identifier: 00889024562875
• UDI-Public: (01)00889024562875(17)290930(10)64507513
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K181947
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42542006702
• Device Lot Number: 64507513
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/12/2021
• Supplement Date Received by Manufacturer: 02/25/2021
• Initial Report FDA Received Date: 02/04/2021
• Supplement Report FDA Received Date: 03/01/2021
• 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: ITEM 42560007514 LOT 64729078