MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CPS TRANSVERSE PIN 6PK 36MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	03/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was discarded by the facility.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products and mdrs: 178560 cps short anchor plug 18mm lot# 331790.Mdr: 0001825034-2021-00942.178512 cps nut co-cr-mo alloy lot# 987810.Mdr: 0001825034-2021-00943.178366 cps sm sht spdl w pins 600lbf lot# 625680.Mdr: 0001825034-2021-00945.178542 cps centering sleeve 20mm lot# 558170.Mdr: 0001825034-2021-00946.150468 oss 11cm diaphyseal segment lot# 699180.Mdr: 0001825034-2021-00947.178711 cps/oss 5cm tpr adapt w/oss sc lot# 795110.Mdr: 0001825034-2021-00948.
Event or Problem Description
It was reported that a patient was implanted with the oss system.The patient was revised on approximately 5 months post procedure due to a fracture of the bone around and above an oss short compress anchor plug.The patient underwent revision surgery and due to remaining bone stock, had to be revised with an im total femur.Patient had thinning of cortical wall due to antibiotic spacer while custom oss femur was created.
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.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing.X-rays were provided and reviewed by a health care professional.Review found periprosthetic fracture of the proximal right femur resulting in loosening of the femoral implant and malalignment with moderate fracture angulation.Bone quality is osteopenic and there is post-operative lucency within the proximal femur.Medical records were not provided.This complaint was confirmed.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.

• Brand Name: CPS TRANSVERSE PIN 6PK 36MM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11598384
• Report Number: 0001825034-2021-00944
• Device Sequence Number: 14345263
• Product Code: JDI
• UDI-Device Identifier: 00880304260535
• UDI-Public: (01)00880304260535(17)270330(10)808960
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K043547
• 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): 08/02/2021

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: 178528
• Device Lot Number: 808960
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/05/2021
• Supplement Date Received by Manufacturer: 07/27/2021
• Initial Report FDA Received Date: 03/31/2021
• Supplement Report FDA Received Date: 08/02/2021
• 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 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 86