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

Catalog Number UNK_REC

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

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

Event Date 01/09/2017

Event Type  Injury  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

Ceramic head (abg1) broke, hip was implanted several years before.

Manufacturer Narrative

Reported event: an event regarding crack/fracture involving an unknown ceramic head was reported.The event was confirmed.Method & results: -device evaluation and results: visual inspection: visual inspection was completed as part of the material analysis, the report noted that the ceramic head fragments were received.The head was reconstructed.Approximately 100% of the head was returned.Typically these types of fractures are a result of multiple fracture origins.Secondary chipping was observed on a majority of the fracture surfaces and therefore the locations of every fracture origin could not be determined.The reconstruction shows a generally longitudinal fracture pattern.{.} "examination of the machined tapered surfaces showed whitening of the ceramic tapered surface." dimensional inspection: not performed as the part was returned in 5 pieces and as such it was impossible to complete a dimensional inspection functional inspection: not performed as the part was returned in 5 pieces and as such it was impossible to complete a functional inspection a material analysis has been performed.The report found: "the ceramic head: 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 and its morphology is consistent with an overload fracture, with the crack propagating outward from the taper.{.} 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.A continuous circumferential metallic band pattern could not be confirmed on the female taper, therefore the proper seating condition of the trunnion in the taper could not be determined {.} conclusion the ceramic head fractured.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.The insert contained abrasion damage consistent with contact with the ceramic head fragments on the articulating surface.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".-medical records received and evaluation: a review of the provided medical records by a clinical consultant indicated: "as such, the root cause of this pi failure case is procedure-related regarding cup malposition through absent anteversion and inappropriate use of a hooded liner thereby causing peak contact forces in the articulation".-device history review could not be performed as the device lot is unknown.-complaint history review could not be performed as the device lot is unknown.Conclusions: the medical review concluded - "cup malposition in absent anteversion and low effective inclination through inappropriate use of a hooded liner has contributed to an overload condition in the arthroplasty contributing to a ceramic fracture after 15-years of implantation".Even though the effected part in this pi is unknown it is know that howmedica osteonics issued a product recall in 2001 relating to the potential breakage of zirconia heads.Reference phn3202 and pw45/01.If additional information and/or device become available, this investigation will be reopened.

Event Description

Ceramic head (abg1) broke, hip was implanted several years before.

• Brand Name: ABG I CERAMIC HEAD
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: jadwiga degrado ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6300910
• MDR Text Key: 66496772
• Report Number: 0002249697-2017-00449
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• 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: 04/10/2017

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_REC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/10/2017
• Initial Date FDA Received: 02/03/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/10/2017
• 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: 75 YR