MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CPS SM SHT SPDL W PINS 800LBF; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 178558 - cps short anchor plug - 671340, 178528 - cps transverse pin - 097450, 178540 - cps centering sleeve - 527300, 178512 - cps nut co-cr-mo alloy - 099480, 150410 - oss tibial poly bearing - 002730, 150478 - oss poly lock pin - 772830, 150417 - oss non-mod tib plate short 67 - 761070, 178715 - cps 8.5cm seg fm oss tpr lt - 507400, 150476 - oss poly tibial bushing - 416430, 150493 - oss reinforced yoke - 666210, 150477 - oss poly femoral bushings - 915230, 150480 - oss axle - 942460.The customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product was not returned by the patient.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: 0001825034-2021-01301, 0001825034-2021-01302, 0001825034-2021-01304, 0001825034-2021-01305.
Event or Problem Description
It was reported the patient underwent a revision approximately 18 months post implantation due to a broken compress.Attempts have been made and no further information has been provided.
Event or Problem Description
Upon receiving additional information of the reported event, it was determined to be not reportable.The initial report should be voided.
Additional Manufacturer Narrative
Upon receiving additional information of the reported event, it was determined to be not reportable.The initial report should be voided.

• Brand Name: CPS SM SHT SPDL W PINS 800LBF
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11752737
• Report Number: 0001825034-2021-01303
• Device Sequence Number: 19868123
• Product Code: MBF
• UDI-Device Identifier: 00880304508910
• UDI-Public: (01)00880304508910(17)290812(10)905950
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K183553
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 05/05/2021

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: 178367
• Device Lot Number: 905950
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/08/2021
• Supplement Date Received by Manufacturer: 05/04/2021
• Initial Report FDA Received Date: 04/30/2021
• Supplement Report FDA Received Date: 05/05/2021
• 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