MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CPS SHORT ANCHOR PLUG 12MM; PROSTHESIS, KNEE

Model Number	178554
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Fall (1848); Failure of Implant (1924); Pain (1994)
Date of Event	06/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a total knee arthroplasty.Subsequently, the patient fell, which resulted in pain and an inability to stand up.Examination revealed that the root part of the anchor plug implant had fractured.Subsequently, a revision surgery was performed.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: medical product: cps xs sht spdl w pins: catalog#178363, lot#418040; cps/oss 5cm tpr adapt w/oss sc: catalog#178711, lot#942410; cps centering sleeve 14mm: catalog#178536, lot#694120; oss rs 14mm ls tibial bearing: catalog#161095, lot#796120; oss rs axle: catalog#161035, lot#689930; oss rs poly fem bushings set/2: catalog#161034, lot#353990; oss rs 9cm mod prox tib body: catalog#161027, lot#376450; oss rs 5cm resurfacing rt: catalog#151803, lot#555740; oss cmntd prox tib stem 11x150: catalog#150445, lot#125540; oss poly bumper lock pin: catalog#150510, lot#704100; oss reinforced yoke: catalog#150493, lot#046330; oss poly lock pin: catalog#150478, lot#887350; oss poly tibial bushing: catalog#150476, lot#173270; biomet bone cement r 1x40: catalog#110035372, lot#y04bai2201.Report source: foreign: japan.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product has been discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual and dimensional evaluations of the product could not be performed as no product was returned nor were pictures provided.Device history record was reviewed and no discrepancies related 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 report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information at time of this report.

• Brand Name: CPS SHORT ANCHOR PLUG 12MM
• 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: 14829524
• Report Number: 0001825034-2022-01464
• Device Sequence Number: 2367209
• Product Code: KWA
• UDI-Device Identifier: 00880304461703
• UDI-Public: (01)00880304461703(17)291213(10)037940
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K062998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2022

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: 178554
• Device Catalogue Number: 178554
• Device Lot Number: 037940
• Was Device Available for Evaluation?: No
• 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: 06/02/2022
• Supplement Date Received by Manufacturer: 10/12/2022
• Initial Report FDA Received Date: 06/27/2022
• Supplement Report FDA Received Date: 10/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2019
• 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
• 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