MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. FEMORAL COMPONENT PRECOAT SIZE D LEFT; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical devices: articular surface size cd 10 mm height, catalog#: 00596203010, lot#: 63680665.Stemmed tibial component precoat size 3, catalog#: 00598003701, lot#: 63890371.Inset all poly patella standard size 26 mm diameter 7.5 mm thickness cemented, catalog#: 00597206526, lot#: 63984291.Report source, foreign source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that patient underwent a left knee revision three years post implantation due to infection and femoral collapse.
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 3007963827-2021-00229.
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 3007963827-2021-00229.

• Brand Name: FEMORAL COMPONENT PRECOAT SIZE D LEFT
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• MDR Report Key: 11931424
• Report Number: 3007963827-2021-00124
• Device Sequence Number: 14548183
• Product Code: JWH
• UDI-Device Identifier: 00889024000995
• UDI-Public: (01)00889024000995(17)271231(10)63889110
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2021

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: 00596001451
• Device Lot Number: 63889110
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/10/2021
• Supplement Date Received by Manufacturer: 09/22/2021
• Initial Report FDA Received Date: 06/03/2021
• Supplement Report FDA Received Date: 10/06/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention