MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH REVITAN DIST. CURVED 24/260; PRESS-FIT HIP FEMUR PROSTHESIS, MODULAR

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924); Pain (1994); Osteopenia/ Osteoporosis (2651)

Event Date 06/04/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source - foreign: 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 the connection pin of the hip stem fractured approximately eight years after initial surgery.Revision surgery was performed.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.D10 - medical devices: revitan prox.Cylindrical 55; item#: 01.00402.055; lot# 2767330.Cocr head 28/+4 lg 12/14; item#: 14.28.07-20; lot#: 2773449.Unknown insert diameter 54.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 initial left total hip arthroplasty on unknown date.Subsequently 8 years later a 1st stage revision was performed due to pain and periprosthetic femur fracture and implant fracture.The cup and head were also excised.Stem was left in place resulting in a girdlestone situation, no weight bearing, and wheelchair for mobilization.A 2nd stage revision was performed 8 days later with incision extending to just above knee for access.Noted cortical bone extremely thin when performing a wagner osteotomy to excise stem that was extensive and laborious.Components exchanged with competitor products utilizing zimmer biomet bone cement.Attempts have been made and no further information has been provided.

Event Description

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

Manufacturer Narrative

(b)(4).Visual examination of the returned product identified that the distal and proximal components of the stem show damage from the revision surgery in the form of scratches and nicks, and a cut perpendicular to the stem axis can be seen in the distal stem, probably from an oscillating saw.No bone ongrowth can be seen on the anchoring surface of the proximal component.On the anchoring surface of the distal component remains of bone cement and little remains of bone attachments can be seen.The connection pin of the distal component is fractured in the not blasted area.The progression marks on the fracture surfaces point to a fatigue fracture with the origin located on the lateral side.Medical records were provided and reviewed by a health care professional.Review of the available records identified initial left total hip arthroplasty.Subsequently, the patient underwent a 1st stage revision due to pain, periprosthetic femur fracture and implant fracture.The cup and head were excised, the stem was well fixed and could not be removed, which resulted in a girdlestone situation.During the 2nd stage revision surgery the stem was removed and new components were implanted.Radiographs were provided and reviewed by a radiologist.Review identified two views of the left hip which demonstrate a left total hip arthroplasty with cement fixation throughout the left femoral diaphysis and cement fixation of the acetabular cup.Two views of the left hip demonstrate interval removal of the femoral neck and head portion of the arthroplasty with possible fracture involving the greater and lesser trochanter.Severe osteopenia is present.Two views of the left hip demonstrate significant interval revision surgery with new acetabular cup as well as new femoral component with long stem status post resection of the proximal and mid diaphysis of the femur with distal cerclage wire.Surgical skin staples and subcutaneous emphysema from recent surgery.Cement still seen within the medullary space of the distal femur.Based on the visual examination and the medical records, it is evident that the stem was cemented.However, according to the surgical technique valid at the time of implantation, the distal stem is intended for cementless fixation.In addition, the smallest proximal component was used, which according to the literature can lead to a proximal position of the modular connection, which increases the mechanical stresses on the taper and thus increases the risk for stem fracture by fatigue.Review of the device history records identified no deviations or anomalies during manufacturing.Device is used for treatment.The reported revitan stem and head were combined with products from another manufacturer, which is a product combination not authorized by zimmer biomet.It is possible that insufficient medial bone support of the proximal component in combination with patient factors such as weight and activity level as well as procedure-related factors such as the combination and implantation technique of the selected implants led or contributed to the reported event.Nevertheless, since the cause may be multifactorial, consisting of patient- and procedure-related factors, a single definitive root cause could not be identified.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.

• Brand Name: REVITAN DIST. CURVED 24/260
• 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: 15957522
• MDR Text Key: 305241375
• Report Number: 0009613350-2022-00621
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 00889024503328
• UDI-Public: (01)00889024503328(17)180630(10)2712951
• 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,Followup
• Report Date: 03/06/2023

1 Device was Involved in the Event

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: 01.00406.324
• Device Lot Number: 2712951
• 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: 11/15/2022
• Initial Date FDA Received: 12/12/2022
• Supplement Dates Manufacturer Received: 01/25/2023; 03/06/2023
• Supplement Dates FDA Received: 02/20/2023; 03/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/30/2013
• 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: 86 YR
• Patient Sex: Female