MAUDE Adverse Event Report: ZIMMER GMBH UNKNOWN BURCH-SCHNEIDER HIP IMPLANT

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Failure of Implant (1924)

Event Date 03/14/2008

Event Type  Injury  

Manufacturer Narrative

X-rays were received and will be reviewed as part of ongoing investigation.The manufacturer did not receive the device for investigation.As no lot number was provided, the device history records could not be reviewed.An e-mail requesting the following additional information was sent to the appropriate representatives: ref# and lot#.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).

Event Description

Patient was implanted with an unknown burch schneider hip implant.Subsequently, patient was revised due to progressive loosening under the cup, visible on x-rays and a fatigue fracture between the cup and the flange.

Event Description

Investigation is completed.

Manufacturer Narrative

Investigation results were made available.Additional: h2, h6 correction: b4, b5, g4, g7, h10 event description: it was reported that the patient suffered a severe acetabular fracture during a car accident at the age of 24, which was treated in (b)(6) 2002 with tha prostheses from jri orthopaedics ltd.Due to loosening the tha was revised after 1.7 years in vivo on (b)(6) 2004.During revision surgery spongiosa of the posterior iliac crest was used for reconstruction of the acetabulum and a burch-schneider cage fixed with screws has been implanted.In the course of events the burch-schneider cage loosened, fractured and was revised after 3.5 years in vivo on (b)(6) 2008.Review of received data: - powerpoint presentation: there are photographs of three x-rays from (b)(6) 2002 to (b)(6) 2004 showing implants from jri orthopaedics: - x-ray labelled (b)(6) 2002 shows a left tha with joint dislocation - x-ray labelled (b)(6) 2004 shows a left tha - x-ray labelled (b)(6) 2004 intraoperative x-ray showing two perpendicular screw parts without screw heads there are six x-rays showing the follow-up of the burch-schneider cage: - x-ray labelled (b)(6) 2004 shows a new left tha with acetabular reconstruction using a burch-schneider cage with three screws and as mentioned in the description spongiosa from the posterior iliac crest was used for acetabular reconstruction.There is a femoral periprosthetic fracture fixed with two cerclage wires.- x-ray labelled (b)(6) 2004 shows an acetabular reconstruction using a burch-schneider cage.The fractured screw parts from the previous implantation are still in situ.- x-ray labelled (b)(6) 2005 compared to the previous x-ray there might be a slight increase in radiolucency around the screw placed in the cup area of the burch-schneider cage and some radiolucency along the cage, nevertheless due to different color and image quality no detailed comparison is possible.- x-ray labelled (b)(6) 2005 possible increase in radiolucency along the cage (comparison to previous x-ray difficult due to difference in image angle) and fracture of the connection between cage and flange clearly visible in one position and indication given of fracture in a second position.Fracture of screws placed at flange.- x-ray labelled (b)(6) 2007 preoperative image shows increase in radiolucency along the cage, fracture of the cage at the connection between cage and flange and fracture of the screws at the flange.- x-ray labelled (b)(6) 2011 3.25 years post acetabular revision shows reconstructed left acetabulum with some screw parts left in situ from previous surgeries and well integrated femoral prosthesis.X-ray description from surgeon states: after well seated postoperative placement, indication of loosening after 1 year in vivo beneath the cage.Width of radiolucent line increased after 2 years and a fissure of the cage is visible.After 3 years in vivo clear breakage between cage and flange and patient complains of pain leading to revision of the cage.Based on multiple tissue samples a low-grade infection with cns was identified.Further, a photograph of retrieved products (revision date (b)(6) 2004 after 1.7 years in vivo) shows a furlong hac stem and a fulong hac csf cup from jri orthopaedics ltd., additionally three screw parts and a small ceramic part can be seen.- patient data according to powerpoint presentation, v-l.M., female, born (b)(6) 1976.- course of events: (b)(6) - car accident leading to left hip luxation of spanish female which was brought from the dominican republic back to spain after the accident.- (b)(6) 2001 - external hip fixation 4-8 months.Infection along the screw and screw has been left in situ.- (b)(6) - post-traumatic coxarthrosis left and implantation of tha (jri orthopaedics).- (b)(6) 2003 - patient has pain, is walking with crutches and has limited range of motion.- (b)(6) 2004 - tha revision cup is loose, stem is firmly seated.Bacteriology is negative.Additionally, implantation of a ktep.- (b)(6) 2005 / 12 jul 2005 - x-rays from spain show firmly seated stem and a seam line along the cage.- (b)(6) 2006 - x-ray from spain showing broad seam line beneath cage, horizontal screws fractured through strap and fracture between cage and flange.- (b)(6) 2007 - x-ray from spain showing fracture between cage and flange.Prosthesis displaced cranially onto bony support.- (b)(6) 2008 - revision with debridement and re-implantation of me müller cup.- (b)(6) 2011 - postoperative biology shows staph.Neg.Treated by antibiosis.- (b)(6) 2012 - mail of patient states that hip is fine.Interpretation of the case by the surgeon: - possible low grad infection at revision in 2004, which led to osteolysis after 1 year in vivo, which led in the subsequent year to the screw fractures and the fracture of the burch-schneider cage.During revision an infection with cns was found.- surgical report, dated (b)(6) 2004: surgical report was reviewed with the following findings: - during removal of the femoral stem, the dorsal trochanter fragment breaks off dorsally - the ceramic cup is smashed in order to remove it - one screw can be removed, the other cannot be retrieved - cup can easily be removed - the last screw can finally be removed - insertion of the spongiosa from the posterior iliac crest, insertion of the burch-schneider cage and fixation with screws - cementing of a pe inlay size 50 - impaction of a revision stem ii 16/225 and fixation with two cerlage wires - additional fixation at the trochanter with a pds cord devices analysis: - no product was returned to zimmer biomet for in-depth analysis, as they were discarded after removal.Review of product documentation: - all involved devices are intended for treatment.- the compatibility check could not be performed as the reference numbers of the involved products are unknown and can no longer be reconstructed.- dhr review could not be performed as ref and lot number are unknown and can no longer be reconstructed by the hospital.Conclusion summary: review of the received medical documentation and course of events showed that the female patient had a severe car accident abroad on (b)(6) 2001 at the age of 24 involving a left hip luxation.The patient was treated in spain with products from jri orthopaedics ltd.Due to complications the patient was transferred to switzerland and underwent a left htep revision on (b)(6) 2004 with implantation of a burch-schneider cage, sl revision stem and ceramic-polyethylene articulation.Bacteriology was negative.In the 3.5 years after the revision the burch-schneider cage became loose, the cage fractured at the intersection between cage and flange and the screws at the flange fractured.The cage was revised on (b)(6) 2008.During the revision surgery a central nervous system (cns) infection was identified.Due to unknown reference number of the burch-schneider cage and other involved products, the manufacturing data incl.Sterilization certificates, the product history and the product compatibility could not be reviewed.Based on the available medical history it could be assumed that the loosening of the cage led to the fracture of the cage and the screws.Nevertheless, the reason for the loosening of the cage remains unknown.An infection after implantation in 2004 could not be identified based on the received medical records.Based on the available medical history it is hypothesized that the main part of the cage was loose while the flange was well fixed with the screws.It is assumed that due to this situation it came to an overload of the flange at one point in time which led to the fracture.The loosening of the cage may have also contributed to the fracture of the screws due to migrations.It is assumed that multiple factors might have played a role in the fractures such as biomechanical unstable situation and loose cage.Other factors, besides the above mentioned, that may have played a role remain unknown.In conclusion, based on the document based investigation no exact root cause could be found.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 cmp-(b)(4).

• Brand Name: UNKNOWN BURCH-SCHNEIDER HIP IMPLANT
• Type of Device: UNKNOWN
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 9265145
• MDR Text Key: 164589170
• Report Number: 0009613350-2019-00640
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 06/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2019
• 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 BURCH-SCHNEIDER HIP IM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 32 YR