MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE WITH HINGE POST EXTENSION SCREW ENCLOSED; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	05/16/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical product: femoral component size d left, item # 00588001401, lot # 63209868, tibial component precoat size 3, item # 00588000300, lot # 63582483, prc agmt block post sz d 5mm, item # 00599003401, lot # 62732398, prc agmt block dist sz d 10mm, item # 00599003420, lot # 62533558, prc agmt block dist sz d 10mm, item # 00599003420, lot # 62600802.Stem extension straight 13mm dia x 100mm length (combined length 145mm) item # 00598801013, lot # 63518631.Report source: (b)(4).Customer has not indicated whether or not the product will be returned to zimmer biomet for investigation.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 a patient was revised approximately three years and two weeks post implantation due to dislocation.At diagnosis it was discovered that the hinge post came off.There is no additional information available at this time.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.Updated: b4, b5, g4, g7, h1, h2, h3, h6, and h10.No product was returned or pictures provided; therefore, visual and dimensional evaluations could not be performed.X-rays were provided and reviewed by a health care professional.Review found left total knee arthroplasty with posterior dislocation of the tibia likely secondary to a posteriorly located hinge post.Possible loosening of the femoral component.Large ossific density along the lateral femoral condyle possibly representing dislocated patella versus fracture fragment.Osteopenia device history record (dhr) was reviewed for deviations and/ or anomalies with no deviations / anomalies identified.A definitive root cause cannot be determined.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
No further event information available at the time of this report.

• Brand Name: ARTICULAR SURFACE WITH HINGE POST EXTENSION SCREW ENCLOSED
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10158442
• Report Number: 0001822565-2020-02103
• Device Sequence Number: 3468222
• Product Code: KRO
• UDI-Device Identifier: 00889024199347
• UDI-Public: (01)00889024199347
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K013385
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2020

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 Expiration Date: 02/29/2020
• Device Model Number: N/A
• Device Catalogue Number: 00588004023
• Device Lot Number: 62973447
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/03/2020
• Supplement Date Received by Manufacturer: 09/24/2020
• Initial Report FDA Received Date: 06/16/2020
• Supplement Report FDA Received Date: 09/29/2020
• 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