MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOMET 360 TIBIAL TRAY 75MM WITH LOCKING BAR & SCREW; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Unstable (1667); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Ambulation or Postural Difficulties (2544); Peripheral Nervous Injury (4414)
Date of Event	10/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant devices - vanguard interlok cruciate retaining femoral component 62.5mm right catalog #: 183006 lot #: 183006, biomet splined knee stem v2 14mm x 80mm with screw catalog #: 148304 lot #: 116310, biomet 360 tibial cruciate wing size small catalog #: 185650 lot #: 962100, series a standard patella 34mm 3 peg catalog #: 184766 lot #: 418150, vanguard anterior stabilized tibial bearing 16mm x 75mm catalog #: 189086 lot #: 048620.The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the devices remain implanted.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 patient; please see all reports associated with this event: 0001825034-2021-02857, 0001825034-2021-02859, 0001825034-2021-02860.Investigation incomplete.
Event or Problem Description
It was reported that the patient presented with increased pain approximately two (2) years following right knee arthroplasty.Since then, the patient has additionally reported instability, severe peroneal neuropathy, difficulty bending the knee and tenderness of the knee and was subsequently treated with corticosteroid injections approximately five (5) years post-operatively.The patient has requested a revision of the knee, however, the surgeon is hesitant to perform due to limited options should any further complications occur.Attempts have been made, however, no additional information is available at this time.
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.Medical records provided confirmed the reported pain, instability and loosening of the tibial and femoral components.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information provided.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: BIOMET 360 TIBIAL TRAY 75MM WITH LOCKING BAR & SCREW
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12623636
• Report Number: 0001825034-2021-02858
• Device Sequence Number: 14481391
• Product Code: JWH
• UDI-Device Identifier: 00880304481435
• UDI-Public: (01)00880304481435(17)260331(10)511410
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K093293
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2022

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: 03/31/2026
• Device Model Number: N/A
• Device Catalogue Number: 185204
• Device Lot Number: 511410
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2021
• Supplement Date Received by Manufacturer: 02/17/2022
• Initial Report FDA Received Date: 10/13/2021
• Supplement Report FDA Received Date: 03/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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: Required Intervention
• Patient Sex: Female
• Patient Weight: 73 KG