MAUDE Adverse Event Report: ZIMMER GMBH FEMORAL HEAD HIP; N/A

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

The manufacturer did not receive x-rays, or other source 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.Attempts to obtain additional information have been made; however, no more is avail able.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.(b)(4).Item and lot numbers unknown.

Event Description

It was reported that the femoral head was implanted on an unknown date and fractured on an unknown date.It is unknown whether revision surgery has been performed.

Manufacturer Narrative

Additional information which was received on may 14, 2020.This follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.The manufacturer received other source documents for review.Should additional information become available and/or the device 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 date and underwent revision due to implant fracture.Revision happened 9 years after the implantation.

Manufacturer Narrative

Investigation results were made available.Event description: it was reported that the femoral head was implanted on an unknown date and fractured approx.After 9 years in-vivo on an unknown date.Revision has taken place on an unknown date.Review of received data: surgical report: the anonymized surgical report has been received.The date and the product part numbers cannot be seen as they have been blackened or have not been listed.Diagnosis: conus fracture of a short stem prosthesis left following implantation 9 years ago.Treatment: removal of the fractured short stem as well as removal of broken off conus and head parts.Replacement of the inlay, rule out of a cup loosening, insertion of a mp stem (210/14/s) and a biolox head 36/s, cerclage wires and an antirotation plate lcp.Anamnesis: the patient bent over and suddenly hip became instable.Weight bearing was no longer possible.The x-ray examination revealed a conus fracture above the implanted short stem with dislocation of the hip.Description of procedure (summary): approach according to watson-jones.Upon opening of the capsule bloody secretion.Removal of the broken off conus.No indication of cup loosening given.Removal of the inlay and insertion of a new inlay and a head of size 36.Display of the stem.Windowing of the femur to assist the removal process of the prosthesis, nevertheless, the prosthesis is well fixed in the front and the back part.During the attempt to push out the stem from below, an oblique shaft fracture occurred below the prosthesis due to the intended breaking point and the rotational movement.The stem has to be completely separated from the bone in order to remove it, and is retained for further examination.Preparation of the femur and insertion of a mp stem.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 as the part number of the product is unknown.Conclusion: it was reported that the femoral head was implanted on an unknown date and fractured approx.After 9 years in-vivo on an unknown date.Revision has taken place on an unknown date.Neither x-rays nor the device or photos of the device were received; therefore the condition of the component is unknown.Patient factors that may have affected the performance of the components such as bone quality, activity level, type of activity (low impact vs.High impact), and relevant medical history are unknown.Adherence to rehabilitation protocol is unknown.Due to significant lack of information a detailed investigation could not be performed, nevertheless based on the given information there is no indication of a nonconformance or complaint out of box (coob).Based on the lack of information and the due to unavailability of the product an in-depth investigation could not be performed.Therefore, no exact root cause could be identified.The need for corrective measures is not indicated and zimmer gmbh considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).

Event Description

Investigation completed.

• Brand Name: FEMORAL HEAD HIP
• Type of Device: N/A
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 10051317
• MDR Text Key: 190756944
• Report Number: 0009613350-2020-00215
• Device Sequence Number: 1
• Product Code: KXA
• 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: 08/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2020
• 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
• Date Manufacturer Received: 08/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention