MAUDE Adverse Event Report: ZIMMER GMBH REVITANÂ, DISTAL PART, CURVED, UNCEMENTED, 16/200; HIP PROSTHESIS

Model Number N/A

Device Problems Fracture (1260); Device Dislodged or Dislocated (2923)

Patient Problem Failure of Implant (1924)

Event Date 10/18/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Foreign source: germany.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that during a check-up at neuenbürg hospital, implant failure with cone fracture of the left hip was identified.Revision surgery took place approximately one month prior to this report.During the revision procedure metallosis was observed.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.Distal and proximal part of the stem were received for examination.The stem was received disassociated at the connection between the connection pin and the proximal part.The distal part and the connection pin are still assembled.Revision damage in the form of deep scratches can be seen on the distal part.No signs of bone ongrowth on the distal part.On the proximal part it is possible to see light scratches most likely coming from revision surgery.On the neck of the taper there is a large polished area.No signs of bone ongrowth on the proximal part.The press-fit region of the proximal part is no longer in its original shape: the wall on the medial-posterior side is extremely deformed and thinned; the inside surface on the press-fit region shows heavy signs of wearing to the point that material was taken away.This damages are most likely due to movement of the disassociated pin in the press-fit region.Review of the manufacturing records identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.With the available information, a definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report 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: REVITANÂ, DISTAL PART, CURVED, UNCEMENTED, 16/200
• Type of Device: HIP PROSTHESIS
• 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: 15796327
• MDR Text Key: 303625423
• Report Number: 0009613350-2022-00590
• Device Sequence Number: 1
• Product Code: JDH
• 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: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: N/A
• Device Catalogue Number: 0100406216
• Device Lot Number: 2983569
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2019
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female