MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH REVITAN, DISTAL PART, CURVED, UNCEMENTED, 24/200; PRESS-FIT HIP FEMUR PROSTHESIS, MODULAR

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 06/19/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).G2 ¿ foreign ¿ germany.D10- revitan, proximal part, cylindrical, uncemented, 105, taper 12/14, item # 0100402105, lot#2737723.Investigation of this incident is currently ongoing.A followup/final report will be submitted when additional information.Becomes available.

Event Description

It was reported that patient underwent a total hip arthroplasty surgery and approximately 9 year later a revision surgery was performed due to the implant fracture.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Corrected: d2; d4(udi); g4: product is not cleared in us but is similar to k192236.Radiographs were provided and reviewed by a health care professional.The review identified initial imaging demonstrating loosening of the left femoral implant with subsequent revision and normal appearance.Subsequent imaging demonstrates a non-displaced lateral cortical fracture and extensive lucency along the femoral implant with probable loosening.The distal and proximal revitan stems were received with the cocr head mounted on the proximal stem and the conical nut disassembled.The distal and proximal stems show damages from the revision surgery in the form of scratches and nicks.No bone ingrowth can be seen on the anchoring surface of the proximal stem.Further, especially medially and on the lateral surface polished areas can be found.On the anchoring surface of the distal stem little bone attachments can be found.The distal tip has multiple nicks, especially on the lateral side, most likely from the removal process during the revision surgery.The connection pin of the distal stem is fractured in the non-blasted area and the proximal part of the connection pin is still assembled to the proximal part of the stem.Two areas can be seen on the fracture surfaces, one with a very fine structure and one with a coarser structure, which points to a fatigue fracture.The blackish discoloration visible on the fracture surfaces can most likely be attributed to oxidation processes.On the proximal fracture part of the connection pin, surface changes adjacent to the fracture surface can be found, especially anterolateral.Closer inspection of these changes with a low power microscope revealed polishing, smeared material, fretting and corrosion.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.With the information provided, we are unable to provide further analysis of the complaint reported or draw any definitive conclusions as to the root cause of the reported issue.A summary of the investigation as been provided to the customer.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

No additional event information to report at this time.

• Brand Name: REVITAN, DISTAL PART, CURVED, UNCEMENTED, 24/200
• Type of Device: PRESS-FIT HIP FEMUR PROSTHESIS, MODULAR
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING 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: 17359099
• MDR Text Key: 319372013
• Report Number: 0009613350-2023-00350
• Device Sequence Number: 1
• Product Code: KWY
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/19/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2018
• Device Model Number: N/A
• Device Catalogue Number: 01.00406.224
• Device Lot Number: 2706028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/23/2023
• Initial Date FDA Received: 07/20/2023
• Supplement Dates Manufacturer Received: 12/08/2023
• Supplement Dates FDA Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2013
• 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 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male