MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CPS ANCHOR PLUG 16MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Date of Event	01/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical devices: item 178353 lot 235640; item 178716 lot 528700; item 178540 lot 487990; item 178527 lot 730840; item 178512 lot 025940.Foreign (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.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: 0001825034-2021-00350.
Event or Problem Description
It was reported that the patient had a total knee arthroplasty and four months after the procedure subsequently was revised due to implant fracture.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
X-rays were received and reviewed by a third party hcp noting the right knee arthroplasty has long stemmed hinged prosthesis with fractured proximal femoral component.Overall fit and alignment is appropriate.Normal bone quality.Dhr was reviewed and no discrepancies were found.The root cause is unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.Visual examination of the returned device found the anchor plug shaft has fractured off into the cps sm spdl.Dimensional analysis of the product determined that the product, where measured, was conforming to print specifications.Device was submitted for further analysis.Analysis determined the device suspected to have fractured due to fatigue.Fatigue mode of fracture identified in the non-smeared areas of the fracture, exhibiting fatigue striations.Eds semi-quantitative elemental analysis of the cps anchor plug showed that it was consistent with ti-6al-4v alloy.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: CPS ANCHOR PLUG 16MM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 11294194
• Report Number: 0001825034-2021-00349
• Device Sequence Number: 19718647
• Product Code: LPH
• UDI-Device Identifier: 00880304259744
• UDI-Public: (01)00880304259744(17)260127(10)445710
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/29/2022

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 Expiration Date: 01/27/2026
• Device Model Number: N/A
• Device Catalogue Number: 178406
• Device Lot Number: 445710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/29/2021
• Supplement Date Received by Manufacturer: 04/14/2021; 04/26/2022
• Initial Report FDA Received Date: 02/08/2021
• Supplement Report FDA Received Date: 04/20/2021; 04/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2016
• 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: Unknown
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown