MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BM FND TIB TY POL COCR PC 87MM; PROSTHESIS KNEE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Necrosis (1971); Pain (1994)
Date of Event	12/14/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported patient underwent a revision procedure four years post implantation due to pain, swelling and fracture of patellar component.No more information is available.
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: vngd ps open por fmrl rt 72.5 catalog # 184513 lot # 333400, vngd ps tib brg 12x87/91mm catalog # 183682 lot # 634550, bmet regenx pri tib tray 79mm cocr 79mm catalog # 141275 lot # 768030, finned tibial stem 35mm catalog # 141314.1 lot # 673260.Customer has indicated that the product will not be returned because product 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
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of pictures provided.Visual evaluation of the returned device pictures shows the 3 pegs are fractured off the device.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.Medical records review indicates patient had been experiencing chronic pain in his patella and x-ray demonstrates failure of the patella with breakage of the component.During the revision small amount of black tissue present and patella was removed and all 3 pegs had broken off, these were also removed 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.H6 - type of investigation - device not returned is n/a which was reported on initial report.Complaint sample was evaluated and the reported event was confirmed.Visual evaluation of the returned device shows signs of being implanted wear/discoloration and three of the posts have fractured off.The root cause of the patella peg fracture was determined to be a labeling and training deficiency as the surgical technique addendum for installation of regenerex patella failed to include guidance on depth line indication on the peg drill bit.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: BM FND TIB TY POL COCR PC 87MM
• Common Device Name: PROSTHESIS KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15820711
• Report Number: 0001825034-2022-02622
• Device Sequence Number: 16922466
• Product Code: MBH
• UDI-Device Identifier: 00880304554429
• UDI-Public: (01)00880304554429(17)161204(10)716120
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K171054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/27/2023

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 Expiration Date: 12/04/2021
• Device Model Number: N/A
• Device Catalogue Number: 141357
• Device Lot Number: 716120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 10/25/2022
• Supplement Date Received by Manufacturer: 03/07/2023; 09/26/2023
• Initial Report FDA Received Date: 11/17/2022
• Supplement Report FDA Received Date: 03/08/2023; 09/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2016
• 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: Male