MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPRESS SHORT ANCHOR PLUG 12MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a right knee revision approximately seven months post-implantation due to an unknown failure of the compress prosthesis.No additional patient consequences were reported.
Additional Manufacturer Narrative
(b)(4).D10 medical devices: compress/oss 5cm tpr adapt w/oss sc catalog#: 178711 lot#: 65766806; compress centering sleeve 14mm catalog#: 178536 lot#: 396780; compress short anchor plug 12mm catalog#: 178554 lot#: 201390; compress transverse pin 6pk 32mm catalog#: 178527 lot#: 501730; compress transverse pin 6pk 36mm catalog#: 178528 lot#: 562900; compress xs sht spdl w pins 800lbf catalog#: 178364 lot#: 625580; compress nut co-cr-mo alloy catalog#: 178512 lot#: 65753467; oss rs axle catalog#: 161035 lot#: 65816757; oss poly tibial bushing catalog#: 150476 lot#: 299680; oss reinforced yoke catalog#: 150493 lot#: 65985059; oss poly lock pin catalog#: 150478 lot#: 65734013; oss rs poly fem bushings set/2 catalog#: 161034 lot#: 65795550; oss rs 12mm ls tibial bearing catalog#: 161094 lot#: 66043842; oss por straight stem 10.5x150 catalog#: 150448 lot#: 905350; oss mod tib baseplate 67mm catalog#: 150421 lot#: 65922750; oss segmental stacking adapter catalog#: 150483 lot#: 65904622; oss 5cm diaphyseal segment catalog#: 150465 lot#: 705810; oss rs 7 cm mod seg fmrl-rt catalog#: 161011 lot#: 612060; tibial perimeter cone right size large catalog#: 42545001523 lot#: 64627887; tibial central cone size large catalog#: 42545000513 lot#: 65076064.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it was not returned by the hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
Upon reassessment of the reported event, it was identified that this device did not cause or contribute to the reported event.This complaint has been reported under 0001825034-2024-01007.
Event or Problem Description
Upon reassessment of the reported event, it was identified that this device did not cause or contribute to the reported event.This complaint has been reported under 0001825034-2024-01007.

• Brand Name: COMPRESS SHORT ANCHOR PLUG 12MM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19097921
• Report Number: 0001825034-2024-01009
• Device Sequence Number: 12614412
• Product Code: KRO
• UDI-Device Identifier: 00880304461703
• UDI-Public: (01)00880304461703(17)330727(10)65889607
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K062998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2024

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: 178554
• Device Lot Number: 65889607
• 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: 03/18/2024
• Supplement Date Received by Manufacturer: 08/29/2024
• Initial Report FDA Received Date: 04/12/2024
• Supplement Report FDA Received Date: 09/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/02/2023
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown