MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CPS ANCHOR PLUG 14MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	09/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Report source: foreign country: (b)(6).Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned product identified that the anchor plug #178404 has fractured.Medical records were provided and reviewed by a health care professional.Review of the available records identified the hinged prosthesis right total knee arthroplasty with long stem femoral and tibial components.There is a distal femoral resection.There is implant disassembly involving the proximal femoral component at the compress spindle along with posterior dislocation of the femoral stem.The device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was 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
It was reported the patient¿s right knee was revised approximately one month post implantation due to loosening, disassociation, and dislocation of the femoral components.Attempts have been made and additional information on the reported event is unavailable.

• Brand Name: CPS ANCHOR PLUG 14MM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9561770
• Report Number: 0001825034-2020-00173
• Device Sequence Number: 2245695
• Product Code: KRO
• UDI-Device Identifier: 00880304002890
• UDI-Public: (01)00880304002890
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K031804
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/07/2020

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: 03/23/2026
• Device Model Number: N/A
• Device Catalogue Number: 178404
• Device Lot Number: 989170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2019
• Initial Report FDA Received Date: 01/07/2020
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention