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

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Joint Dislocation (2374)

Event Date 09/20/2023

Event Type  Injury  

Event 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.

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.

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 Description

No further event information available at the time of this report.

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 Description

No further event information available at the time of this report.

• Brand Name: POLYETHYLENE INSERT XT SIZE B
• Type of Device: 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
• MDR Text Key: 325314608
• Report Number: 0001822565-2023-02796
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 00889024633889
• UDI-Public: (01)00889024633889(17)270329(10)65322745
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K150028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 82 KG