MAUDE Adverse Event Report: ZIMMER GMBH UNKNOWN HIP SCREW

Model Number N/A

Device Problems Fracture (1260); Metal Shedding Debris (1804)

Patient Problem No Information (3190)

Event Date 03/10/2015

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.Additional information has been requested and is currently not available.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

It was reported that the patient was implanted an unknown hip implant on the left side on (b)(6) 1987 and the patient underwent revision surgery on (b)(6) 2015 due to fracture of the fixation screw.During surgery, metallosis around the ring was detected.As exact implantation date is unknown the last day of the year reported is taken in this report.

Manufacturer Narrative

As the case at hand was initiated due to received additional information from an other event ((b)(4)) it is not suspected that the device or additional information is being submitted for review.Additional information was requested and is currently not available.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.No trend analysis could be performed as no item number is available.As no lot numbers were provided for the devices, the device history records could not be reviewed.The missing device data information was requested and is currently not available.Event description (event details, per): event summary: it is reported that the patient has undergone left hip revision of a mueller ring on (b)(6) 2015 due to fracture of the fixation screw.During surgery, metallosis around the ring was detected.The patient was implanted in 1987.Exact date is unknown, we take the last day of the year reported.Review of received data: a picture of an ap pelvic x-ray dated (b)(6) 2016 was received.Additionally, another picture of an ap pelvic x-ray was received.However, the latter is partially covered by the image of a slice of a ct scan dated (b)(6) 2017.However, these are not relevant, as taken after revision occurred.Surgical reports of implantation and revision and other consultation reports are available for review.The available reports are in french, were translated in house and are summarized as follows.Only the information relevant to this complaint is summarized here below: the surgical report of the dated (b)(6) 2015 describes the revision on the left hip after approx.28 years in vivo due to loosening of a müller ring and breakage the fixation screws.The reports describe the presence of some liquid serum, a granuloma between the cup and the ring as well as some metallosis.The ring is mobile and the anchoring screws fractured.The stem is removed in order simplify the acetabular reconstruction and allow an elongation of the neck.The stem is extracted from the cement without difficulty.The femur is prepared and the cup and ring removed.The only difficulty is the removal of the fractured screw parts, which is required for the preparation of the acetabulum.A defect of the acetabular superior acetabulum.The new components are then implanted and the surgery completed.No product was returned to zimmer biomet for in-depth analysis.The device has been requested and is currently not available.According to the information received, the location is unknown.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 the issue evaluation assessment.Additionally, the implant performed for approximately 28 years in vivo.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 the issue evaluation assessment.Additionally, the implant performed for approximately 28 years in vivo.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 the issue evaluation assessment.Additionally, the implant performed for approximately 28 years in vivo.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 the issue evaluation assessment.Additionally, the implant performed for approximately 28 years in vivo.Aseptic loosening due to release of wear particles (metal and cement), bone to cage / cage to cement screw to cage / screw to cement: possible: it is reported that some metallosis was found around the implants and that the 4 screws were fractured.Aseptic loosening due to failure of connection ring / cage and bone screw: possible: it is reported that some metallosis was found around the implants and that the 4 screws were fractured.Aseptic loosening due to loss of binding safety of the cement interfaces: ring / cage - bone cement - cup: not possible: nothing is reported regarding cement failure.Fracture of implant due to micro cracks due to laser marking in high stressed implant areas: possible: the implants were not returned for investigation, thus it cannot be excluded.However, additionally, the implant performed for approximately 28 years in vivo.Fracture/ damage / loosening of implant due to patient disregards limits of the device, wrong behavior of the patient, high patient activity: possible: the implant performed for approximately 28 years in vivo.However, this point cannot be excluded.Failure/ fracture of implant due to mechanical properties of the material different from specified properties (quality requirements): not possible: a systematic issue with design and/or material properties would have been detected as part of the issue evaluation assessment.Additionally, the implant performed for approximately 28 years in vivo.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: possible: the implants were not returned for investigation, thus it cannot be excluded.However, additionally, the implant performed for approximately 28 years in vivo.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: not possible: nothing is reported regarding mri.Stress shielding leading to aseptic loosening due to incorrect distribution of load due to insufficient bony support of implant: not possible: it is reported that some metallosis was found around the implants and that the 4 screws were fractured.Nothing suggest insufficient bone quality.Additionally, the implant performed for approximately 28 years in vivo.Impingement with stem (decreased rom), dislocation, subluxation, migration of implant, stress shielding due to malpositioning of the implant, wrong alignment: not possible: the implant performed for approximately 28 years in vivo.Malpositioning would have led earlier to implant failure.Failure / fracture of implant due to damage of implant during implantation (e.G.Damage of malleable parts as flanges etc.): not possible: the implant performed for approximately 28 years in vivo.Damage of implant during implantation would have led earlier to implant failure.Failure of implant due to combination with competitor products: possible: the product reference are not available.Thus, compatibility cannot be checked.Aseptic loosening due to wrong cementing technique: not possible: the implant performed for approximately 28 years in vivo.Wrong cementing technique would have led earlier to implant failure.Failure of implant due to use of implant outside indication range (off label use): possible: the product reference as well as x-rays are not available.Thus, off-label use cannot be checked.Release of particles eg.Metal ions , pe particles due to inadequate material pairing: not possible: a systematic issue with design and/or material properties would have been detected as part of the issue evaluation assessment.Additionally, the implant performed for approximately 28 years in vivo.Increased wear, loosening or fracture of components due to patient with high body weight: possible: the patient is reported to weight 81-87 kg.However, it is unknown if during the 28 years in vivo the patient was heavier.Mechanical failure of the device due to reuse of the device which is intended for single use: not possible: nothing suggest reuse of a device.Conclusion summary: it is reported that the patient has undergone left hip revision of a mueller ring on (b)(6) 2015 due to loosening and fracture of 4 fixation screws.During surgery, metallosis around the ring was detected.It has to be mentioned that the implants were implanted in 1987 and performed in vivo for approximately 28 years.An exact root cause for loosening and screw fracture cannot be determined.The need for corrective measures is not indicated and zimmer biomet considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).

• Brand Name: UNKNOWN HIP SCREW
• 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7013285
• MDR Text Key: 91442033
• Report Number: 0009613350-2017-01531
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2017
• 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: UNKOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2018
• 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
• Patient Age: 68 YR
• Patient Weight: 87