MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH REVITAN DISTAL STEM

Model Number N/A

Device Problems Fracture (1260); Material Integrity Problem (2978)

Patient Problem Failure of Implant (1924)

Event Date 02/17/2021

Event Type  Injury  

Manufacturer Narrative

Medical products: revitan proximal stem hip impl win gen; catalog #: unknown; lot #: unknown.Therapy date: (b)(6) 2021.The manufacturer received other source of documents for review.The manufacturer did not receive the device for investigation.As no lot number was provided, the device history records could not be reviewed.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

Patient was implanted on an unknown side and underwent a revision surgery due to implant fracture.

Manufacturer Narrative

This follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.Additional information was received on mar 15, 2021.The manufacturer received x-rays and other source documents for review.Should additional information become available and /or the device(s) be returned for evaluation and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.Zimmer¿s reference number of this file is (b)(4).

Event Description

Patient was implanted on an unknown side and underwent a revision surgery due to implant fracture.This is the second revision surgery.Patient was implanted initially on an unknown date in 1994 and underwent first revision surgery on an unknown date in 2002.

Manufacturer Narrative

This follow-up report is being submitted to relay corrected and additional information.Additional: h2, h6 correction: b4, g3, g6, h10.Event description: it was reported that the patient was implanted in the right hip with a revitan stem on an unknown date and underwent revision surgery on (b)(6) 2021 due to implant fracture.Further, it was reported that the patient had initial surgery in 1994 and underwent revision surgery in 2002.However, it remains unknown what devices were revised in 2002.Review of received data: - due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.- x-rays: the following x-ray analysis was performed by a radiologist.Two ap views and a cross table lateral view of the hip and proximal right femur from (b)(6) 2020 were received.There is a fracture of the proximal aspect of the femoral implant with mild angulation.No osseous fracture or dislocation is noted.Multiple cerclage wires are present and intact.Radiolucency is noted along the femoral implant greatest proximally and medially most likely related to the original implant prior to revision.- patient data: c.M., male, born on (b)(6) 1950, 87kg, 178cm.Product evaluation: - no product was returned; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: - device purpose: this device is intended for treatment.- product compatibility: the compatibility check could not be performed due to missing product identification.- dhr review: review of the device history records could not be performed due to missing product identification.Conclusion: it was reported that the patient was implanted in the right hip with a revitan stem on an unknown date and underwent revision surgery on (b)(6) 2021 due to implant fracture.Further, it was reported that the patient had initial surgery in 1994 and underwent revision surgery in 2002.However, it remains unknown what devices were revised in 2002.Review of the manufacturing records, the complaint history and the product compatibility could not be performed due to unknown product identification.Further, due to the unavailability of the product, a visual examination could not be performed.Based on the evaluation of the x-ray images provided, the reported stem fracture can be confirmed.However, due to the lack of additional medical data and product, we were unable to determine a specific cause for this complaint.Based on the known information, a nonconformity or a "complaint out of box" (coob) was not determined.The need for corrective measures is not indicated and zimmer switzerland manufacturing gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

No change to previously reported event.

• Brand Name: REVITAN DISTAL STEM
• Type of Device: REVITAN DISTAL STEM
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 11398224
• MDR Text Key: 234234572
• Report Number: 0009613350-2021-00112
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/27/2021

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 Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/17/2021
• Initial Date FDA Received: 03/02/2021
• Supplement Dates Manufacturer Received: 03/15/2021; 09/20/2021
• Supplement Dates FDA Received: 03/26/2021; 09/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 87