MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH REVITAN®, DISTAL PART, STRAIGHT, UNCEMENTED, 18/200; HIP PROSTHESIS

Model Number N/A

Device Problems Fracture (1260); Patient-Device Incompatibility (2682)

Patient Problems Failure of Implant (1924); Pain (1994); Metal Related Pathology (4530)

Event Date 02/07/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products:¿item#: 14.28.05-20, lot#: 2484853, item name: "cocr head 28/-4 s 12/14" , item#: 01.00401.075, lot#: 2454215, item name: revitan prox.Spout 75.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 patient underwent left hip revision surgery due to the implant fracture and metallosis about fourteen (14) years after the initial surgery.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Event Description

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

Manufacturer Narrative

The revitan stem and the cocr 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 proximal part shows some polished areas on the medial side.Bone attachments can be found on the anchoring surface of the distal part.On the lateral side of the distal part, there are revision damages in the form of a cut and a drill hole.The cut was most likely caused during osteotomy, while the drill hole was used to remove the stem.The cocr head shows some scratches and marks from an electrocautery tool on the articulating surface; while on the rim of the head some small scratches are present.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 locking screw of the proximal part shows some scratches.A review of the device manufacturing records confirmed no abnormalities or deviations.Device is used for treatment.Medical records were provided and reviewed by a health care professional: the patient underwent an x-ray examination due to left hip pain and instability on loading.The results of this radiographical examination pointed to a possible fracture of the connection pin of the revitan stem.Subsequently, the patient underwent revision surgery.Surgical notes of this procedure report extraction of fluid with the appearance of metallosis before incision of the hip, wear of the liner, loosening of the proximal part due to fracture of the connection pin and good osteointegration of the distal part.Additionally, signs of osteolysis were identified in the area of the acetabulum.During the revision, a mix of competitor and zb products were explanted.A total of five undated x-rays, allegedly taken before revision surgery, were provided and reviewed by a radiologist: the received radiographs show one ap overview of both hips, three ap views and an oblique view of the left hip.A mild superolateral position of the femoral head was noted and an elevated acetabular cup abduction angle of about 57°.Abnormal radiolucency reflecting osteolysis is noted along the shell and in gruen zones 1 and 7 of the femoral implant.An undated intraoperative photograph was received and assessed but is not documented, as it does not provide any additional information.Based on the investigation, a fracture of the connection pin of the revitan stem can be confirmed.The characteristics of the fracture surfaces point to a fatigue fracture.Additionally, it was determined that zimmer biomet products were used together with products from another manufacturer.Zimmer biomet has not confirmed the compatibility for this combination of devices.It is unknown if this off-label use caused 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.

• Brand Name: REVITAN®, DISTAL PART, STRAIGHT, UNCEMENTED, 18/200
• Type of Device: HIP PROSTHESIS
• 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: 16730663
• MDR Text Key: 313188299
• Report Number: 0009613350-2023-00161
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 00889024592902
• UDI-Public: (01)00889024592902(17)121130(10)2419385
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/10/2023

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: 11/30/2012
• Device Model Number: N/A
• Device Catalogue Number: 01.00405.218
• Device Lot Number: 2419385
• 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: 04/05/2023
• Initial Date FDA Received: 04/13/2023
• Supplement Dates Manufacturer Received: 07/06/2023
• Supplement Dates FDA Received: 07/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2007
• 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
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 80 KG