MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CPS/OSS 5CM TPR ADAPT W/OSS SC 5CM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 178552 - cps short anchor plug 10mm - 611200; 178512 - cps nut co-cr-mo alloy - 250400; 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: 0001825034-2021-01936, 0001825034-2021-01937, 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; b7; d6a; g3; g6; h1; h2.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.Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.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
Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.

• Brand Name: CPS/OSS 5CM TPR ADAPT W/OSS SC 5CM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12094358
• Report Number: 0001825034-2021-01938
• Device Sequence Number: 3235899
• Product Code: KWA
• UDI-Device Identifier: 00880304430792
• UDI-Public: (01)00880304430792(17)300603(10)490530
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K043547
• 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: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/27/2021

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: 178711
• Device Lot Number: 490530
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/16/2021
• Supplement Date Received by Manufacturer: 07/02/2021; 07/27/2021
• Initial Report FDA Received Date: 06/30/2021
• Supplement Report FDA Received Date: 07/13/2021; 07/28/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention