MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOMET ILOK PRI TIB TRAY 71MM; PROSTHESIS, KNEE

Catalog Number	141213
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Ambulation or Postural Difficulties (2544); Joint Laxity (4526)
Date of Event	11/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent initial right total knee arthroplasty.The patient did well until nearly a year later when the patient began to experience pain, instability, audible clicking, and limited flexion due to arthrofibrosis.Metal allergy testing confirmed a reactivity to nickel.The surgeon attributed the patient¿s instability to nickel within the titanium components.Subsequently, one year post-implantation, the patient underwent open incisional biopsy followed by radical debridement and a revision of all tibial and femoral components.A competitor system was implanted and the original patella was retained.Due diligence is in progress for this event; to date no further information has been reported.
Additional Manufacturer Narrative
(b)(4).D10: medical product: unknown vanguard size 65 femoral component: catalog#ni, lot#ni; unknown vanguard 10mm cr articular surface: catalog#ni, lot#ni; unknown 8mm patella component: catalog#ni, lot#ni.Multiple mdr reports have been filed for this event, please see associated reports: 0001825034-2023-02420; 0001825034-2023-02421.The product will not be returned to zimmer biomet for investigation, as the product location is unknown.The investigation is in process.Upon receipt of additional information or completion of the investigation, a follow-up mdr will be submitted.
Event or Problem Description
No further event information at time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.D10: medical product: vngd ti fem cr 65mm rt: catalog#cp113618, lot#933290; tibial bearing cruciate retaining (cr) 71/75 mm width 10mm thickness: catalog#ve183440, lot#64396956; biomet finned pri stem 40mm: catalog#141314, lot#343790; series (b)(6) peg: catalog#184764, lot#539210.An additional mdr report has been filed for this event, please see associated report: 0001825034-2023-02619.The investigation is in process.Upon completion of the investigation, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The device history record was reviewed and no discrepancies relevant to the reported event were found.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: x-rays reveal good fit of the prosthesis, knee stable without effusion, patient tripped bruising both knees, patient reports having trouble sleeping with pain radiating down the side of her knee and uses a cane for ambulation, mildly reactive to aluminum, chromium, iron and reactive to nickel, patient injured a disc in her spine when they fell, knee soreness with stiffness from favoring one side while walking, instability on valgus varus, clicking, flexion limited to 90 degrees, arthrofibrosis.A definitive root cause cannot be determined.However, the reported product contains the alleged allergen and could be a possible cause.The complaint is confirmed via medical records.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: BIOMET ILOK PRI TIB TRAY 71MM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17957015
• Report Number: 0001825034-2023-02422
• Device Sequence Number: 7120200
• Product Code: JWH
• UDI-Device Identifier: 00887868247781
• UDI-Public: (01)00887868247781(17)311015(10)808980
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K171054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• 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,Followup
• Report Date (Section B): 04/24/2024

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 Catalogue Number: 141213
• Device Lot Number: 808980
• 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: 09/26/2023
• Supplement Date Received by Manufacturer: 10/13/2023; 04/24/2024
• Initial Report FDA Received Date: 10/18/2023
• Supplement Report FDA Received Date: 11/07/2023; 04/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2021
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.; SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 98 KG