MAUDE Adverse Event Report: ZIMMER GMBH ALLOFIT ALLOCLASSIC SHELL; ALLOFIT ACETABULAR SYSTEM

Model Number N/A

Device Problem Detachment Of Device Component (1104)

Patient Problems Injury (2348); Joint Dislocation (2374)

Event Date 11/29/2016

Event Type  Injury  

Manufacturer Narrative

The manufacturer did not receive devices, x-rays, or other source documents for review.As no lot numbers were provided for the devices, the device history records could not be reviewed.A cause for this specific event cannot be ascertained from the information provided.Should additional information become available and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.Zimmer¿s reference number of this file is (b)(4).

Event Description

It was reported that a patient was implanted on the right hip side with an alloclassic cup on an unknown date.Patient underwent revision surgery on (b)(6) 2016 due to dislocation and stem subsidence.

Manufacturer Narrative

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 reference 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: revision due to dislocation retroverted cup and stem subsidence.Review of received data: - there are 2 x-rays available (pelvis view).The x-rays are undated.On both x-rays it can be seen that a dislocation occurred.The head was dislocated from the cup.The position of the stem is therefore also moved.On one x-ray it can be seen that the patient has prosthesis on both sides.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: - fracture of stem due to insufficient fatigue strength of material.- not possible: a systematic issue with design and/or material properties would have been detected as part of a trend review defined in complaint registration, systematic assessment defined in complaint investigation or in the current pms process post market surveillance.- fracture of stem due to insufficient fatigue strength due to the design.- not possible: a systematic issue with design and/or material properties would have been detected as part of a trend review defined in complaint registration, systematic assessment defined in complaint investigation or in the current pms process post market surveillance.- fracture of stem due to ha coating weakens fatigue strength.- not possible: a systematic issue with design and/or material properties would have been detected as part of a trend review defined in complaint registration, systematic assessment defined in complaint investigation or in the current pms process post market surveillance.- failure of connection between stem and ball head, metallosis due to fretting corrosion - wear.- possible: the products were not received for investigation, therefore cannot be excluded.- failure of connection between stem and ball head due to mechanical properties of the material (wrong material) - not possible: a systematic issue with design and/or material properties would have been detected as part of a trend review defined in complaint registration, systematic assessment defined in complaint investigation or in the current pms process post market surveillance.- luxation and wear of components due to insufficient range of motion for components.- possible: the products were not received for investigation, therefore cannot be excluded.- failure of connection between stem and ball head due to insufficient connection strength between femoral head and stem.- possible: the products were not received for investigation, therefore cannot be excluded.- fracture of stem due to general corrosion (crevice, pitting, galvanic).- possible: the products were not received for investigation, therefore cannot be excluded.- failure of connection between stem and ball head due to corrosion due to wrong material combination.- not possible: a systematic issue with design and/or material properties would have been detected as part of a trend review defined in complaint registration, systematic assessment defined in complaint investigation or in the current pms process post market surveillance.- fracture of stem due to damage of the stem during implantation.- possible: no surgical reports sent or x-rays right after the implantation.- fracture of stem due to selection of stem size not adequate for patient's anatomy (insufficient planning).- possible: no information provided.- fracture of stem due to patient disregards limits of the device.- possible: no patient information provided.Conclusion summary: the devices were not returned for investigation.The x-rays showed that a dislocation was occurred and therefore a revision was performed.There were no surgical reports or patient relevant information provided.It is unknown how the dislocation did occur.The in vivo time is unknown as the date of implantation was not provided.An exact root cause for the dislocation could not be determined.The need for corrective measures is not indicated and zimmer (b)(4) considers this case as closed.(b)(4).

• Brand Name: ALLOFIT ALLOCLASSIC SHELL
• Type of Device: ALLOFIT ACETABULAR SYSTEM
• 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: 6188802
• MDR Text Key: 62840381
• Report Number: 0009613350-2016-01463
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 03/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2016
• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2017
• 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