MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CPS ANCHOR PLUG 14MM; 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	01/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-00579.Medical devices: cps sm spdl with pins 600lbf catalog#: 178354 lot#: 783190.Oss porous im stem 14.5 x 90 catalog#: 150385 lot#: 216820.Oss mod tib baseplate 75mm catalog#: 150423 lot#: 965060.Series a pat thn 34 3 peg catalog#: 184786 lot#: 884720.Oss 3cm diaphysel segment catalog#: 150464 lot#: 345070.Oss poly tibial bushing catalog#: 150476 lot#: 059680.Oss reinforced yoke catalog#: 150493 lot#: 901970.Oss poly lock pin catalog#: 150478 lot#: 923030.Oss poly femoral bushings catalog#:150477 lot#: 096440.Oss axle catalog#: 150480 lot#: 901580.Oss 11cm diaphyseal segment catalog#: 150468 lot#: 795660.Oss 7cm segmental femoral lt catalog#: 150355 lot#: 640610.Oss tibial poly bearing 12mm catalog#:150410 lot#: 111190.Series a pat std 34 3 peg catalog#: 184766 lot#: 764470.Cps/oss 5cm tpr adapt w/oss sc catalog#: 178711 lot#: 549930.Cps transverse pin 6pk 40mm catalog#: 178529 lot#: 205550.Cps centering sleeve 18mm catalog#: 178540 lot#: 665430.Cps nut co-cr-mo alloy catalog#: 178512 lot#: 987740.Product has been received by zimmer biomet and 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 underwent a left knee revision approximately seven months post-implantation due to implant fracture.Attempts to obtain additional information have been made; however, no more is available.
Additional Manufacturer Narrative
Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned product found the shaft of the anchor plug has fractured off into the spindle.Dimensional analysis of the product determined that the product, where measured, was conforming to print specifications.Device was submitted for further analysis.Analysis determined the fracture surface showed excessive smearing for the most part and small non-smeared regions revealing ductile overload dimples, suggesting a possibility of tensile overload mode of failure.Device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to 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: CPS ANCHOR PLUG 14MM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11385238
• Report Number: 0001825034-2021-00580
• Device Sequence Number: 3742459
• Product Code: KRO
• UDI-Device Identifier: 00880304002890
• UDI-Public: (01)00880304002890(17)270814(10)752770
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K031804
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2021

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: 178404
• Device Lot Number: 752770
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/02/2021
• Supplement Date Received by Manufacturer: 04/15/2021
• Initial Report FDA Received Date: 02/26/2021
• Supplement Report FDA Received Date: 04/16/2021
• 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: Hospitalization; Required Intervention
• Patient Age: 45 YR