MAUDE Adverse Event Report: ZIMMER BIOMET, INC. STEM EXTENSION OFFSET 11MM DIA X 100MM LENGTH; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2021-00150 and 0001822565-2021-01607.Medical devices: stemmed tibial component precoat size 5 catalog#: 00598004701 lot#: 63656326.Articular surface with locking screw 14 mm height catalog#: 00599404014 lot#: 62886555.Stem extension offset 11mm dia x 100mm length catalog#: 00598802011 lot#: 63607883.Report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.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 knee revision approximately four years post implantation due to infection.During the revision, it was noted the locking screw had backed out.Attempts to obtain additional information have been made; however, no more is available at this time.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies were found.A definitive root cause cannot be determined for disassociation.However, infection is not related to the implants, therefore, no issue was found with the device.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.

• Brand Name: STEM EXTENSION OFFSET 11MM DIA X 100MM LENGTH
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11967797
• Report Number: 0001822565-2021-01608
• Device Sequence Number: 1375038
• Product Code: JWH
• UDI-Device Identifier: 00889024221444
• UDI-Public: (01)00889024221444(17)270331(10)63607883
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 10/28/2021

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: 00598802011
• Device Lot Number: 63607883
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/27/2021
• Supplement Date Received by Manufacturer: 10/11/2021
• Initial Report FDA Received Date: 06/09/2021
• Supplement Report FDA Received Date: 10/28/2021
• 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