MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BMT SMOOTH KNEE STEM 10X80; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Swelling (2091)
Date of Event	10/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Associated products : item#: cp113123; vngd ti fem ssk 60mm lt; lot#: 289620; item#: 183844; vngd sskpsc tib brg s 14x71/75; lot#: 111550.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it has been discarded.The investigation is in process.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 - 2020 - 04083.
Event or Problem Description
It was reported the patient underwent an initial left tka 6.5 years ago and subsequently underwent a first revision on three years later.Patient underwent a second revision on last month due to pain, swelling, and migration of the femoral component.Femoral component was "tamped forward but not loose".Femoral components were removed, tibia was well fixed.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records.No product was returned; visual and dimensional evaluations could not be performed.Device history record (dhr) was reviewed and no discrepancies were found.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: pain and swelling, migration of femoral component despite fully cemented stem.Tibia well fixed, femoral component was tamped forward but not loose.Femoral components removed.Computer navigation assisted cuts.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: BMT SMOOTH KNEE STEM 10X80
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10829063
• Report Number: 0001825034-2020-04084
• Device Sequence Number: 17093405
• Product Code: JWH
• UDI-Device Identifier: 00880304460737
• UDI-Public: (01)00880304460737
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K142933
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2021

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 Expiration Date: 07/28/2026
• Device Model Number: N/A
• Device Catalogue Number: 145020
• Device Lot Number: 810150
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/19/2020
• Supplement Date Received by Manufacturer: 01/07/2021
• Initial Report FDA Received Date: 11/12/2020
• Supplement Report FDA Received Date: 01/11/2021
• 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