MAUDE Adverse Event Report: ZIMMER GMBH UNKNOWN ALLOCLASSIC STEM; PROSTHESIS, HIP

Model Number N/A

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

Patient Problem Failure of Implant (1924)

Event Date 12/13/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10.Metasulâ® epsilonâ¿¢ standard insert 55/32 item# 437232155 lot# unknown 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.

Event Description

It was reported approximately one month ago that a patient underwent a hip arthroplasty on an unknown date.Subsequently, it was confirmed that the patient underwent a revision for loosening of the stem.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records could not be performed due to missing lot number.Device is used for treatment.Due to insufficient product information, the compatibility of the involved products could not be verified.A review of the complaint history could not be performed due to missing reference and lot numbers.Two radiographs were received and reviewed by a radiologist.Both images shows the left hip of the patient.In both case it is possible to see a cement fixation of the acetabular cup.As the femoral components are different, it is possible to conclude that the images are taken at a different timepoint: most likely x-ray 2 is taken before revision surgery, while x-ray 1 is taken after revision surgery.In both cases cortical thickening is present both medially and laterally within the proximal femoral diaphysis.No acute fracture.Radiolucency along the lateral aspect of the proximal femoral component on x-ray 2 is present that might indicate loosening of the femora stem.With the available information, a definitive root cause could not 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 Description

Diligence is complete and additional information on the reported event is unavailable at this time.

• Brand Name: UNKNOWN ALLOCLASSIC STEM
• Type of Device: PROSTHESIS, HIP
• 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: 18412474
• MDR Text Key: 331540517
• Report Number: 0009613350-2023-00724
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2023
• 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 ALLOCLASSIC STEM
• 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: 02/12/2024
• 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: SEE H10.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 69 YR
• Patient Sex: Male