MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CPS SHORT ANCHOR PLUG 10MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Material Twisted/Bent (2981); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Failure of Implant (1924)
Date of Event	06/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical devices: 178512 - cps nut co-cr-mo alloy - 250400; 178711 - cps/oss 5cm tpr adapt w/oss sc 5cm - 490530; 178525 - cps transverse pin 6pk 24mm m - 524250; 178364 - cps xs sht spdl w pins 800lbf - 814940; 178367 - cps sm sht spdl w pins 800lbf - 235970; 150483 - oss segmental stacking adapter - 933720; 161011 - oss rs 7 cm mod seg fmrl-rt - 678610; 150476 - oss poly tibial bushing - 221860; 150478 - oss poly lock pin - 490730; 150493 - oss reinforced yoke - 570110; 161034 - oss rs poly fem bushings set/2 - 494980; 161035 - oss rs axle - 619830; 161018 - oss rs non-mod plate short 59 - 728720; 150466 - oss 7cm diahpyseal segment - 119960; 161094 - oss rs 12mm ls tibial bearing - 887140.The customer has indicated that the product will not be returned to zimmer biomet for investigation.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: 0001825034-2021-01937, 0001825034-2021-01938, 0001825034-2021-01939, 0001825034-2021-01940, 0001825034-2021-01941.
Event or Problem Description
It was reported the patient underwent a right knee procedure.Subsequently, the patient was scheduled to be revised due to a failed compress.The patient then underwent a revision surgery one week after initial implantation.Attempts have been made and no further information has been provided.
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.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 the patient underwent a right knee procedure.Subsequently, the patient was scheduled to be revised due to a failed compress.The patient then underwent a revision surgery one week after initial implantation.The traction bar appears to have bent.The surgeon stated he is unsure if the fractured bone was an effect or a cause of the failed compress.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.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.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The device history record was reviewed and no discrepancies relevant to the reported event were found.Review of complaint history found no additional related issues for this item and the reported part and lot combination.X-rays were provided and reviewed by a health care professional.Review of the available records identified the following: periprosthetic fracture at the mid to distal femoral diaphysis with mild apex lateral angulation.Alignment is abnormal with apex lateral angulation between the bone and hardware interface.Bone quality appears normal.A definitive root cause cannot 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 available at the time of this report.

• Brand Name: CPS SHORT ANCHOR PLUG 10MM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12094379
• Report Number: 0001825034-2021-01936
• Device Sequence Number: 14411059
• Product Code: KWA
• UDI-Device Identifier: 00880304461659
• UDI-Public: (01)00880304461659(17)290529(10)611200
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K062998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/22/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 178552
• Device Lot Number: 611200
• 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: 06/16/2021
• Supplement Date Received by Manufacturer: 07/02/2021; 07/27/2021; 11/22/2021
• Initial Report FDA Received Date: 06/30/2021
• Supplement Report FDA Received Date: 07/13/2021; 07/28/2021; 11/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2019
• 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
• 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.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 14 YR
• Patient Sex: Female