MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FLUTED STEM EXTENSION STRAIGHT PRECOAT; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Pain (1994); Swelling (2091); No Code Available (3191)
Date of Event	06/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: patient previously underwent surgeries for femoral fracture and enterobacter infection.A definitive root cause cannot be determined.Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product has been discarded.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-0923.
Event or Problem Description
It was reported that patient had a total knee arthroplasty and was revised due to disassociation, severe pain, swelling, and drainage associated with a previous infection.Attempts have been made and no further information has been provided.

• Brand Name: FLUTED STEM EXTENSION STRAIGHT PRECOAT
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11156970
• Report Number: 0001822565-2021-00138
• Device Sequence Number: 642454
• Product Code: KRO
• UDI-Device Identifier: 00889024197732
• UDI-Public: (01)00889024197732(10)290430(10)64287779
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K070978
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/12/2021

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: 00585205012
• Device Lot Number: 64287779
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2021
• Initial Report FDA Received Date: 01/12/2021
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Weight: 136