MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH REVITAN, DISTAL PART, CURVED, UNCEMENTED, 20/200; HIP PROTHESIS

Model Number N/A

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Bone Fracture(s) (1870); Pain (1994); Osteolysis (2377); Metal Related Pathology (4530)

Event Date 03/12/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10 - revitanâ®, proximal part, cylindrical, uncemented, 75, taper 12/14, item#0100402075 lot#2931498.Biolox delta hd 12/14 36x+7, item#00-8775-036-04, lot#29152252.Continuum tm shell multi 62 nn, item#00-8757-062-02, lot#63764594.Hxpe liner elevated nn, 36 item#00-8752-015-36, lot#63659905.G2 - foreign - spain.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 patient underwent a revision due to the accumulation of local metallic accumulations associated with granulomas and bone destruction, approximately four (4) years, ten (10) months from initial hip arthroplasty.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 corrected information.The revitan stem and the biolox head were returned for investigation.The distal and proximal parts of the revitan stem show damages from the revision surgery in the form of scratches and nicks.No bone ongrowth can be seen on the anchoring surface of the proximal part.The neck of the stem taper shows a deep recess on the posterior side.The lateral side of the proximal part is polished and shows a deep recess.Comparing the position of the two recesses with the x-rays, it is possible to assume that these damages are due to the direct contact against the metal cerclages.The medial side of the proximal part also shows some polished areas most likely due to the contact against the metal cerclages.Bone attachments can be found on the anchoring surface of the distal part.In the proximal area of the distal part, there is a revision damage in the form of a drill hole.The drill hole was most probably used to remove the stem.The connection pin of the distal part is fractured and the patterns on the fracture surfaces point to a fatigue fracture with the origin located on the lateral side.The face surfaces of the distal and the proximal parts are partially polished and worn; in particular, the face surface of the distal part shows material deformation on the lateral side, most likely due to contact of the two parts after the fracture.The bevel of the biolox head shows discoloration on one side.Metal transfer marks are visible on the articulating surface, particularly on one side halfway between the bevel and the highest point of the head.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.Device is used for treatment.A total of three undated x-rays were provided and reviewed by a radiologist.X-ray 1 shows an undated ap view of the left hip.The radiograph shows the presence of a hip implant with an unknown stem.It can be assumed that this image was taken at a time point preceding the implantation of the revitan stem.Lucency surrounding the proximal subtrochanteric portion of the femoral component and some cortical osteolysis in the subtrochanteric lateral femoral diaphysis can be noted.The femoral head is positioned eccentrically within the acetabular cup.X-ray 2 shows an undated ap view of the left hip.Due to the presence of a surgical drain and staples, it can be assumed that the image was taken shortly after implantation of the revitan stem.Here the bone appears normally mineralized and the head well placed within the cup.X-ray 3 shows an undated ap view of the left hip.It can be assumed that the image was taken before the revision surgery.A transversely oriented fracture of the femoral hardware component in the proximal subtrochanteric diaphysis can be seen.Bones appear intact without fracture.Cortical thickening is seen surrounding the proximal femoral diaphysis.No medical records were provided.According to the information received, a revitan stem was implanted.However, based on the received radiographs, it can be assumed that a previous unknown stem was implanted on the left hip before the revitan stem.Due to the lack of medical documentation, no further information is available on this implant.Subsequently, the patient suffered from pain and difficulty walking and underwent revision surgery.During the revision surgery, a fracture of the connection pin located between the proximal cylindrical part and the distal curved part was detected.Bone fragility, metallosis and osteolysis with cortical perforation were appreciated intraoperatively in the area of the fractured connection pin.Varus angulation of components was also noticed.It was reported that the revision surgery was difficult due to the high osteointegration between the stem and the femoral bone.Distal and proximal part of the revitan stem, as well as the biolox head were removed; cup and liner were left in place, as considered in good condition.Based on the device examination and the provided radiographs, it is possible to assume that damages on the surfaces of the proximal part are mostly due to contact against the metal cerclages.If and to what extent this aspect may have contributed to the reported event remains unknown.A fracture of the connection pin of the revitan stem can be confirmed.The characteristics of the fracture surfaces point to a fatigue fracture.Factors such as, but not limited to, surgical technique, patient age, weight, height, activity level, and medical history may have led or contributed to the reported event.In conclusion, since the cause may be multifactorial, consisting of patient- and procedure-related factors, a 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.

Event Description

Attempts have been made and no further information has been provided.

• Brand Name: REVITAN, DISTAL PART, CURVED, UNCEMENTED, 20/200
• Type of Device: HIP PROTHESIS
• 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: 17000479
• MDR Text Key: 315908020
• Report Number: 0009613350-2023-00222
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 00889024593053
• UDI-Public: (01)00889024593053(17)220331(10)2907534
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 08/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 01.00406.220
• Device Lot Number: 2907534
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 100 KG