MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CPS SM SHT SPDL W PINS 600LBF; 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: 0001825034-2021-00943.178528 cps transverse pin 6pk 36mm lot# 808960.Mdr: 0001825034-2021-00944.178542 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 mon ths 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Upon receiving additional information found during investigation of the reported event, it was determined that the part referenced is not believed to have caused or contributed to the event.The initial report was submitted erroneously and should be voided.
Event or Problem Description
This device is not believed to have caused or contributed to the event.

• Brand Name: CPS SM SHT SPDL W PINS 600LBF
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11598568
• Report Number: 0001825034-2021-00945
• Device Sequence Number: 17036801
• Product Code: JDC
• UDI-Device Identifier: 00880304509047
• UDI-Public: (01)00880304509047(17)291014(10)625680
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K101475
• 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: company representative,health
• 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: 178366
• Device Lot Number: 625680
• 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