MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BMET REGENX PRI TIB TRAY 67MM COCR 67MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Medical product: unknown femoral catalog#: ni lot#: ni.Unknown tibial insert catalog#: ni lot#: ni.Report source foreign: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as its current 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 requires a revision due to fracture of the tibial tray.A revision was scheduled but it is unknown if it occurred.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
Reported event was unable to be confirmed due to limited information received from the customer.Medical records were provided and reviewed by a health care professional.Review found possible oblique bone fracture involving the posterior medial tibia.Images are limited.Mmi review does not call out implant fracture.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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: BMET REGENX PRI TIB TRAY 67MM COCR 67MM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11838492
• Report Number: 0001825034-2021-01505
• Device Sequence Number: 14510543
• Product Code: JWH
• UDI-Device Identifier: 00880304463615
• UDI-Public: (01)00880304463615(17)271004(10)067680
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K171054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2021

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: 141272
• Device Lot Number: 067680
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/21/2021
• Supplement Date Received by Manufacturer: 06/01/2021
• Initial Report FDA Received Date: 05/17/2021
• Supplement Report FDA Received Date: 06/03/2021
• 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
• Outcome Attributed to Adverse Event: Other