MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOMET TIBIAL LOCKING BAR; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Edema (1820); Unspecified Infection (1930); Pain (1994); Scar Tissue (2060); Swelling (2091); Impaired Healing (2378); Numbness (2415)
Date of Event	08/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: 141215, tibial tray, lot # 467350, 141314, biomet finned pri stem 40mm, lot # 845380, 183032, femoral component, lot # j6073232, ep-189102, bearing, lot # 976390.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 04502, 0001825034 - 2019 - 04503, 0001825034 - 2019 - 04504, 0001825034 - 2019 - 04505.
Event or Problem Description
It was reported that approximately 2 years post implantation, the patient has been revised due to loosening of the implants and infection.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
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 that approximately 2 years post implantation, the patient was revised due to ongoing infection of the l knee/wound and delayed altered healing.All devices were explanted with a spaced implanted.Loosening of devices was not identified during the revision.Attempts have been made and no further information has been provided.
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.The following sections were updated: b4; b5; g4; g7; h1; h2; h3; h6.Medical records were provided and reviewed by a healthcare professional.Three sessions for treatment for non-healing left knee wound.Chronic pain, swelling, stiffness, numbness/ sensation and difficulty ambulating.Wound break down again and mild chest rash noted on (b)(6)2019 with positive cultures for mssa.Left hardware removal on (b)(6)2019 , thick synovium and cloudy fluid.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Device history record (dhr) 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 report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: BIOMET TIBIAL LOCKING BAR
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9163031
• Report Number: 0001825034-2019-04506
• Device Sequence Number: 2430433
• Product Code: JWH
• UDI-Device Identifier: 00880304009738
• UDI-Public: (01)00880304009738
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K171054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/20/2020

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 Model Number: N/A
• Device Catalogue Number: 141205
• Device Lot Number: 597530
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/18/2019
• Supplement Date Received by Manufacturer: 01/02/2020; 02/20/2020
• Initial Report FDA Received Date: 10/07/2019
• Supplement Report FDA Received Date: 01/15/2020; 02/21/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 49 YR
• Patient Weight: 125