MAUDE Adverse Event Report: ZIMMER GMBH UNKNOWN MÜLLER ROOF REINFORCEMENT RING

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

As for zimmer specialists to perform an in-depth analysis it is required to have all necessary information at hand, it was therefore tried to receive more information for this case.We received an answer explaining that the author is not able to provide any further information due to data privacy policy.A technical investigation was not possible to perform, as the device(s) were not at hand for investigation.Dhr review: 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.Trend analysis: it was not possible to perform a trend analysis, as the catalogue number of the device is unknown.Review of event description: it was reported in the journal article, that 8 patient, which had an muller acetabular roof reinforcement ring implanted, experienced aseptic loosening and underwent revision surgery.No other details were available.Review of received data: no medical data such as x-rays, surgical notes or any other case-relevant documents received.Root cause analysis: 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 a trend review.- 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 a trend review.- aseptic loosening, pain due to insufficient fatigue strength of material and design fracture of implant (mechanical failure).- not possible: a systematic issue with design and/or material properties would have been detected as part of a trend review.- 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 a trend review.- aseptic loosening due to release of wear particles (metal and cement), bone to cage / cage to cement, screw to cage / screw to cement.- not possible: a systematic issue with design and/or material properties would have been detected as part of a trend review.- aseptic loosening due to failure of connection ring / cage and bone screw.- possible: it is only known that 8 patients experienced aseptic loosening and underwent revision surgery.No other details such as x-rays surgical reports, products,patient data, history and compliance are available.Therefore this cannot be excluded.- aseptic loosening due to loss of binding safety of the cement interfaces: ring / cage - bone cement - cup.- possible: it is only known that 8 patients experienced aseptic loosening and underwent revision surgery.No other details such as x-rays surgical reports, products,patient data, history and compliance are available.Therefore this cannot be excluded.- fracture/ damage / loosening of implant due to patient disregards limits of the device, wrong behavior of the patient, high patient activity.- possible: it is only known that 8 patients experienced aseptic loosening and underwent revision surgery.No other details such as x-rays surgical reports, products,patient data, history and compliance are available.Therefore this cannot be excluded.-thermal necrosis and/or implant loosening and impossibility to use mri scanning due to mri - magnetically induced displacement force and torque -radiofrequency induced heating - image artifacts.- possible: it is only known that 8 patients experienced aseptic loosening and underwent revision surgery.No other details such as x-rays surgical reports, products,patient data, history and compliance are available.Therefore this cannot be excluded.- stress shielding leading to aseptic loosening due to incorrect distribution of load due to insufficient bony support of implant - possible: it is only known that 8 patients experienced aseptic loosening and underwent revision surgery.No other details such as x-rays surgical reports, products, patient data, history and compliance are available.Therefore this cannot be excluded.- aseptic loosening due to wrong cementing technique.- possible: it is only known that 8 patients experienced aseptic loosening and underwent revision surgery.No other details such as x-rays surgical reports, products,patient data, history and compliance are available.Therefore this cannot be excluded.- increased wear, loosening or fracture of components due to patient with high body weight.- possible: it is only known that 8 patients experienced aseptic loosening and underwent revision surgery.No other details such as x-rays surgical reports, products,patient data, history and compliance are available.Therefore this cannot be excluded.Conclusion summary: according to the information received in this journal article, eight patients were revised due to loosening.However, no further details about the event are available.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, and 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.(b)(4).

Event Description

It was reported in a journal article that 8 patients were implanted with a müller acetabular roof reinforcement ring (catalogue number unknown) and experienced aseptic loosening and underwent revision surgery.Source: "are porous tantalum cups superior to conventional reinforcement ring?" anders brüggemann, erik fredlund, hans mallmin and nils p hailer (2016) acta orthopaedica.

• Brand Name: UNKNOWN MÜLLER ROOF REINFORCEMENT RING
• Type of Device: UNKNOWN
• 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: 6607186
• MDR Text Key: 76495785
• Report Number: 0009613350-2017-00760
• Device Sequence Number: 1
• Product Code: JDJ
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2017
• 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
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/08/2017
• 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: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention