MAUDE Adverse Event Report: ZIMMER GMBH B-S REINFORCEMENT CAGE HIP IMPLANT; HIP PROSTHESIS

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).All available information is covered in the report at hand.As the case at hand was taken from a journal article it is not suspected that the device or additional information is being submitted for review.A technical investigation was not possible to perform, as the devices were not at hand for investigation.However, based on the available information the investigation is conducted with outcome as follows.Trend analysis: a trend analysis could not be performed as no item number was available.Device history records (dhr): as no lot numbers were provided for the devices, the device history records could not be reviewed.An e-mail requesting missing device data information was sent on december 16, 2016.At zimmer (b)(4) all medical devices prior release to market undergo several quality inspections as defined in our quality procedures.Our quality inspection- and deviation procedures ensure that only products fulfilling the specification are sold.These procedures are part of the overall quality management system at zimmer (b)(4) and get regularly audited by our notified body, competent authorities and internal and external auditors.Thus, for all products sold to the market can be assumed having a complete and correct dhr.Event summary: in the journal article it is mentioned that the patient experienced loosening of the burch schneider cage after 30 months in-vivo.Patient was not revised.Review of received data: no medical data such as x-rays, surgical notes or any other case-relevant documents received.Devices analysis: no product was returned to zimmer biomet for in-depth analysis.Review of product documentation: no product documentation was reviewed for investigation.Root cause determination using dfmea: aseptic loosening due to insufficient primary stability due to design: not possible, a systematic issue with design and/or material properties would have been detected as part of complaint trending defined in complaint registration or in the current pms process post market surveillance; aseptic loosening, migration of implant due to insufficient secondary stability due to surface structure: not possible, a systematic issue with design and/or material properties would have been detected as part of complaint trending defined in complaint registration or in the current pms process post market surveillance.Aseptic loosening, pain due to insufficient fatigue strength of material and design, fracture of implant (mechanical failure of the ring / cage, mechanical failure of the flanges, mechanical failure of the hook, failure of bone screws): not possible, a systematic issue with design and/or material properties would have been detected as part of complaint trending defined in complaint registration or in the current pms process post market surveillance; stress shielding leading to aseptic loosening due to incorrect distribution of load due to design: not possible, a systematic issue with design and/or material properties would have been detected as part of complaint trending defined in complaint registration or in the current pms process post market surveillance; aseptic loosening du to release of wear particles (metal and cement),bone to cage / cage to cementscrew to cage / screw to cement: possible, as affected product was not returned for investigation; aseptic loosening due to failure of connection ring / cage and bone screw: possible, as affected product was not returned for investigation; aseptic loosening due to loss of binding safety of the cement interfaces:ring / cage - bone cement - cup: possible, as affected product was not returned for investigation; fracture/ damage / loosening of implant due to patient disregards limits of the device/wrong behavior of the patient/high patient activity: possible, as no details about patient behavior is known; stress shielding leading to aseptic loosening due to incorrect distribution of load due to insufficient bony support of implant: possible, as no x-rays were provided; aseptic loosening due to wrong cementing technique: possible, as no details about the surgical technique are known; increased wear,loosening or fracture of components due to patient with high body weight: possible, as no patient details are known.Conclusion summary: neither x-rays, operative notes, nor office visit notes were received for a deep assessment.Patient factors that may affect the performance of the components such as bone quality, activity level, type of activity (low impact vs.High impact), relevant medical history and adherence to rehabilitation protocol are unknown.Due to significant lack of information, it is impossible to perform a meaningful analysis of the reported event.Based on the information available for the investigation, an exact root cause could not be determined.The need for corrective measures is not indicated and zimmer (b)(4) considers this case as closed.Zimmer¿s reference number of this file is (b)(4).

Event Description

It was reported in a journal article that the patient experienced loosening after 30 months.No further information is available.(steffen hoell, et al: the burch¿schneider cage for reconstruction after metastatic destruction of the acetabulum: outcome and complications, in: arch orthop trauma surg (2012) 132:405¿410 doi 10.1007/s00402-011-1351-0.).

Manufacturer Narrative

A technical investigation was not possible to perform, as the devices were not at hand for investigation.E-mails requesting missing information were sent.The latest one was sent on february 9, 2017 to (b)(6).As we did not receive an answer, our sales representative visited the hospital personally on (b)(4) 2017.He asked for an appointment with (b)(6) but it was denied.He handed our request letter to the registry at the hospital.We haven't received a response so far.However, based on the available information the investigation is conducted with outcome as follows.Trend analysis: a trend analysis could not be performed as no item number was available device history records (dhr): as no lot numbers were provided for the devices, the device history records could not be reviewed.At zimmer (b)(4) all medical devices prior release to market undergo several quality inspections as defined in our quality procedures.Our quality inspection- and deviation procedures ensure that only products fulfilling the specification are sold.These procedures are part of the overall quality management system at zimmer (b)(4) and get regularly audited by our notified body, competent authorities and internal and external auditors.Thus, for all products sold to the market can be assumed having a complete and correct dhr.Event summary: in the journal article it is mentioned that the patient experienced loosening of the burch schneider cage after 30 months in-vivo.Patient was not revised.Review of received data: no medical data such as x-rays, surgical notes or any other case-relevant documents received devices analysis: no product was returned to zimmer biomet for in-depth analysis.Review of product documentation - clinical review of received journal/article: the received journal/article was thoroughly reviewed and can summarized as followed: due to the existing metastasis, the pre-operative chemotherapy and radiotherapies and the existing pathological fractures, the state of health of the patients and the corresponding acetabulum¿s bone quality and portion was fairly bad.Most patients experienced a decrease of pain after treatment with the burch schneider cage, however, also complications occurred.According to the author of this literature, the complication rate is still comparable with rates of other operation techniques of metastatic acetabular lesions.As described in the instruction for use, cancer is considered a contra-indication.However, as indicated in the applicable surgical technique, a potential implantation in a tumor patient carefully needs to be evaluated first.Based on the current patient population and the final results of the study, the final conclusion made by the author can be supported by zimmer biomet.Implantation of a protrusio cage can improve the quality of life in patients with metastatic disease in the acetabulum, increasing their mobility and reducing pain.The complication rate is comparable with the rates for other surgical methods for metastatic acetabular lesions.For the time being, the provided patient benefit clearly exceeds the potential patient risks.Root cause determination using dfmea: - aseptic loosening due to insufficient primary stability due to design.
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> not possible, a systematic issue with design and/or material properties would have been detected as part of complaint trending defined in complaint registration or in the current pms process post market surveillance.- aseptic loosening, migration of implant due to insufficient secondary stability due to surface structure.
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> not possible, a systematic issue with design and/or material properties would have been detected as part of complaint trending defined in complaint registration or in the current pms process post market surveillance.- aseptic loosening, pain due to insufficient fatigue strength of material and design, fracture of implant (mechanical failure of the ring / cage, mechanical failure of the flanges, mechanical failure of the hook, failure of bone screws).
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> not possible, a systematic issue with design and/or material properties would have been detected as part of complaint trending defined in complaint registration or in the current pms process post market surveillance.- stress shielding leading to aseptic loosening due to incorrect distribution of load due to design.
=
> not possible, a systematic issue with design and/or material properties would have been detected as part of complaint trending defined in complaint registration or in the current pms process post market surveillance.- aseptic loosening du to release of wear particles (metal and cement),bone to cage / cage to cement screw to cage / screw to cement.
=
> possible, as affected product was not returned for investigation.- aseptic loosening due to failure of connection ring / cage and bone screw.
=
> possible, as affected product was not returned for investigation.- aseptic loosening due to loss of binding safety of the cement interfaces:ring / cage - bone cement - cup.
=
> possible, as affected product was not returned for investigation.- fracture/ damage / loosening of implant due to patient disregards limits of the device/wrong behavior of the patient/high patient activity.
=
> possible, as no details about patient behavior is known.- stress shielding leading to aseptic loosening due to incorrect distribution of load due to insufficient bony support of implant.
=
> possible, as no x-rays were provided.- aseptic loosening due to wrong cementing technique.
=
> possible, as no details about the surgical technique are known.- increased wear,loosening or fracture of components due to patient with high body weight.
=
> possible, as no patient details are known.Conclusion summary: neither x-rays, operative notes, nor office visit notes were received for a deep assessment.Patient factors that may affect the performance of the components such as bone quality, activity level, type of activity (low impact vs.High impact), relevant medical history and adherence to rehabilitation protocol are unknown.Due to significant lack of information, determine one specific root cause for the event report.Considering the available information, we consider the following as most probable root cause: patient disregards limits of the device/wrong behavior of the patient/high patient activity, as these factors are out of zb control.However, based on the information available for the investigation, an exact root cause could not be determined.The need for corrective measures is not indicated and zimmer (b)(4) considers this case as closed.Zimmer¿s reference number of this file is (b)(4).

Event Description

It was reported in a journal article that the patient experienced loosening after 30 months.One patient developed significant gill type iii radiological loosening of the bs cage after 30 months and due to poor health was unable to undergo a second procedure.No further information is available.(steffen hoell, et al: the burch¿schneider cage for reconstruction after metastatic destruction of the acetabulum: outcome and complications, in: arch orthop trauma surg (2012) 132:405¿410 doi 10.1007/s00402-011-1351-0.).

• Brand Name: B-S REINFORCEMENT CAGE HIP IMPLANT
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: kevin escapule ; 1800 west center street; warsaw, IN 46580 ; 8006136131
• MDR Report Key: 6262822
• MDR Text Key: 65211226
• Report Number: 0009613350-2017-00063
• Device Sequence Number: 1
• Product Code: KWZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/21/2017

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
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/13/2017
• Initial Date FDA Received: 01/19/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other