MAUDE Adverse Event Report: ZIMMER BIOMET, INC. POLYETHYLENE INSERT XT SIZE B USE WITH DISTAL FEMORAL XT SIZE B; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Product has been received by zimmer biomet and 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 patient underwent a left knee arthroplasty.Subsequently the patient was revised due to the segmental hinge post breaking 3 years after implantation.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4, b5, d10, g3, g6, h1, h10 additional associated products and mdrs 00585002026 articular surface with segmental hinge post size b 26 mm height lot# 61928040 mdr: 0001822565-2021-01555.
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/corrected updated: b4, b5, g3, g6, h1, h2, h3, h6, h10.Visual examination of the returned product identified signs of being in vivo.Both poly box and hinge post was fractured.Device was submitted for further analysis.Analysis determined of hinge post are consistent with fatigue culminating in bending overload.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: no complication noted during the initial and revision surgery.During the follow-up on (b)(6) 2021, the patient experiencing pop noise.Left revision hinge tka, no apparent loosening, no lysis, no radiolucent lines, the hinge post is transected at the bearing junction, anterior dislocation of the knee on the lateral view, severe patella alta.Failure of left tka hardware, likely due to the large poly thickness and patient's large habitus, bmi >45.The complaint is confirmed.A definitive root cause cannot be determined.Per package insert: 87-6204-025-23: fracture, instability is known adverse effect of the system.No corrective actions, preventive actions, or field actions resulted after investigation of this event.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: POLYETHYLENE INSERT XT SIZE B USE WITH DISTAL FEMORAL XT SIZE B
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11797032
• Report Number: 0001822565-2021-01296
• Device Sequence Number: 3661322
• Product Code: KRO
• UDI-Device Identifier: 00889024195639
• UDI-Public: (01)00889024195639(17)240730(10)63412638
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K150028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/26/2021

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 Expiration Date: 06/30/2024
• Device Model Number: N/A
• Device Catalogue Number: 00585001296
• Device Lot Number: 63412638
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/15/2021
• Supplement Date Received by Manufacturer: 05/13/2021; 08/25/2021
• Initial Report FDA Received Date: 05/10/2021
• Supplement Report FDA Received Date: 06/07/2021; 08/27/2021
• 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 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 135