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

Model Number N/A

Device Problems Break (1069); Migration or Expulsion of Device (1395)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

It was discovered that the legal manufacturer of the reported product is zimmer gmbh, winterthur switzerland.The initial report was submitted under mfr report number 0001822565-2016-04495 by zimmer inc., warsaw usa.All available information is covered in the report at hand.A technical investigation was not possible to perform, as the devices were not at hand for investigation.An e-mail requesting missing device data information was sent on december 15, 2016 to the author of the article.An e-mail was received in response from the author, carsten perka (md), on december 16, 2017.He wrote that he was unable to answer our questions as the evaluation happened 18 years ago.However, based on the available information the investigation is conducted with outcome as follows.Device history records (dhr) review results as no lot numbers were provided for the devices, the device history records could not be reviewed.At zimmer gmbh 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 gmbh 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 a trend analysis could not be performed as no item number was available.Event summary: in the journal article it is mentioned that by the first follow-up, (2) two fractured cages had become apparently l oose.Review of received data no medical data such as x-rays, surgical notes or any other case-relevant documents received clinical review of received journal/article: the received journal/article was thoroughly reviewed and can summarized as followed: considering the involved patient population and the results of the study, zimmer biomet can support the author¿s conclusion on this study.For the time being, the provided patient benefit clearly exceeds the potential patient risks and therefore usage of the burch-schneider cage is fully justified for patients where implants that allow bone integration cannot be implanted.Devices analysis a device analysis could not be performed as no product was returned to zimmer biomet for in-depth analysis.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, miigration 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.
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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 due to release of wear particles (metal and cement),bone to cage / cage to cementscrew to cage / screw to cement.
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> possible, as affected product was not returned for investigation.- aseptic loosening due to failure of connection ring / cage and bone screw.
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> 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.
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> possible, as affected product was not returned for investigation.- fracture/ damage / loosening of implant due to patient disregards limits of the device/wrong behavior oft he patient/high patient acitvity.
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> possible, as no details about patient behavior is known.- failure/ fracture of implant due to mechanical properties of the material different from specified properties (quality requirements).
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> possible, as no lot number was provided to check the dhr.- fracture of implant due to general corrosion (crevice, pitting, galvanic)fracture of implant; fracture of ring / cage- fracture of bone screw; failure of connection ring / cage and bone screw.
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> possible, as product was not returned for investigation - stress shielding leading to aseptic loosening due to incorrect distribution of load due to insufficient bony support of implant.
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> possible, as no x-rays were provided.- failure/fracture of implant due to damage of implant during implantation (e.G.Damage of malleable parts as flanges etc.).
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> possible as no implantation report was provided.- aseptic loosening due to wrong cementing technique.
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> possible, as no details about the surgical technique are known.- increased wear,loosening or fracture of components due to patient with high body weight.
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> 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 ofthe patient/high patient acitvity, 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 gmbh considers this case as closed.Zimmer¿s reference number of this file is cmp-0256725.

Event Description

It was reported in a journal article, that patients were implanted with b-s reinforcement cage hip implants on an unknown date.It was reported in the journal artikle that two (2) cages had broken at follow up and were certainly loose.(perka, carsten and ludwig, ralph: reconstruction of segmental defect during revision procedures of the acetabulum with the burch-schneider anti-protrusio cage, in: the journal of arthroplasty (2001) vol.15 no.5.).

• 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: 6405628
• MDR Text Key: 69995652
• Report Number: 0009613350-2017-00378
• 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: Physician
• Type of Report: Initial
• Report Date: 03/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2017
• 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): Other