MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN CERAMIC HEAD; HIP IMPLANT

Catalog Number UNK_SHC

Device Problems Break (1069); Fracture (1260); Material Integrity Problem (2978)

Patient Problems Injury (2348); No Information (3190)

Event Date 03/22/2016

Event Type  Injury  

Manufacturer Narrative

Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.

Event Description

Revision due to a broken ceramic head.

Manufacturer Narrative

The device was returned and evaluated.An event regarding crack/fracture involving an unknown ceramic head was reported.The event was confirmed following visual inspection.Method & results: device evaluation and results: visual inspection was performed as part of the material analysis report (mar).The inspection noted: the ceramic head was fractured.The head was reconstructed.Approximately (b)(6) of the head was returned.Secondary chipping was observed on a majority of the fracture surfaces.The reconstruction shows a generally longitudinal fracture pattern.This type of pattern is created by hoop stresses generated by the wedge-effect of the stem trunnion.The fracture pattern is consistent with the application of the device.Examination of the machined tapered surfaces showed whitening of the ceramic tapered surface.This whitened surface was consistent with the phase transformation of the zirconia from the tetragonal phase to the monoclinic phase, as reported in the clinical literature.That phase transformation can cause internal stresses in the base material.The observed fracture morphology is consistent with an overload fracture, with the crack propagating outward from the taper.Examination of the three fragments that make up the majority portion of the female head taper revealed a circumferential metallic band pattern.This is consistent with the trunnion being properly seated in the taper.Identification markings on the head were not visible.The material analysis report concluded: the insert contained gouging damage consistent with contact with the ceramic head fragments on the articulating surface.The returned fragments of the distal rim exhibited explantation damage.Based on the above, the highly stressed region of the ceramic machined tapered surface had undergone a phase transformation, which may have an effect on the structural integrity of the material.However, clinical and patient history may also play a role in the survivorship of any implant.As neither the clinical information nor the patient history was available at the time of this report, no definitive conclusion can be drawn as to the cause of fracture.This specific implant is no longer available for sale.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as device details, operative reports, x-rays, patient history & follow-up notes are needed to investigate this event further.If additional information becomes available this investigation will be reopened.

Event Description

Revision due to a broken ceramic head.

• Brand Name: UNKNOWN CERAMIC HEAD
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5584903
• MDR Text Key: 42907550
• Report Number: 0002249697-2016-01233
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/22/2016

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SHC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2016
• Initial Date FDA Received: 04/18/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 192