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

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); Joint Dislocation (2374)
Date of Event	09/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient was revised a little over two months post implantation due to pain, dislocation, and implant fracture.The patient contacted the surgeon to discuss discomfort and pain in his left knee.The surgeon suggested that he go for x-rays at the nearest hospital.The result of the x-rays showed a clear dislocation of the left knee.It is also visible that the hinge post and bushings were fractured.Attempts to obtain additional information have been made; however, no more information is available at this time.
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001822565-2023-02797 and 0001822565-2023-02798.D10- concomitant medical product: segment with male/female taper 30 mm length.Item# 00585004603 lot# 65492481 articular surface with segmental hinge post size b 20 mm height item# 00585002020 lot# 64314434.Report source - south africa.H3: customer has indicated that 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.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.Updated: a1, a2, b4, b5, d2, g1, g3, g6, h1, h2, h6, and h10.Corrected: b7.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.Visual examination of the returned pe insert shows that the device is damaged and fractured and the articular surface is fractured and not all pieces were returned.The fracture analysis found: optical images of the device fracture surface showed suspected beach marks and river line artifacts suggesting a possible fatigue mode of failure.Medical records were not provided however, x-ray images were provided but not dated, and would not enhance the investigation process.Device history record (dhr) was reviewed for deviations and/ or anomalies with no deviations / anomalies identified.A definitive root cause cannot be determined.This complaint can be confirmed from the fractured implants that were returned.No problem was found with the returned stem.If any further information is received 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: POLYETHYLENE INSERT XT SIZE B
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17907835
• Report Number: 0001822565-2023-02796
• Device Sequence Number: 15343705
• Product Code: KRO
• UDI-Device Identifier: 00889024633889
• UDI-Public: (01)00889024633889(17)270329(10)65322745
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K150028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/28/2024

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 Model Number: N/A
• Device Catalogue Number: 00585001296
• Device Lot Number: 65322745
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 09/21/2023
• Supplement Date Received by Manufacturer: 12/18/2023; 02/20/2024
• Initial Report FDA Received Date: 10/10/2023
• Supplement Report FDA Received Date: 01/09/2024; 02/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 82 KG