MAUDE Adverse Event Report: ZIMMER GMBH POLYETHYLENE INLAY; PROSTHESIS, KNEE

Model Number N/A

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Abrasion (1689); Failure of Implant (1924); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/19/2024

Event Type  Injury  

Event Description

It was reported that the polyethylene inlay with peg is loosened from the anchorage, resulting in knee instability and increased abrasion.Bone behind femoral shield is soft.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).G2: report source germany h6: health effect - clinical code not available: hemodynamic instability the device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Manufacturer Narrative

(b)(4).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 Description

It was reported that the polyethylene inlay with peg is loosened from the anchorage, resulting in knee instability and increased abrasion.Bone behind femoral shield is soft.The patient underwent right knee revision approximately 16 years post-implantation.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: POLYETHYLENE INLAY
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 18790368
• MDR Text Key: 336354512
• Report Number: 0009613350-2024-00065
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: REVISION STEM 13X123; WALLABY ANCHORAGE STEM
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Sex: Female
• Patient Weight: 92 KG