MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN EXETER STEM; HIP IMPLANT

Catalog Number UNK_SHC

Device Problems Break (1069); Crack (1135); Material Integrity Problem (2978)

Patient Problems Bone Fracture(s) (1870); Pain (1994)

Event Date 02/01/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It is reported that an implanted exeter stem broke.Update: exeter hipstem, implanted in 1997, fractured in (b)(6) 2015.No trauma involved.The fracture was noticed during an inspection.The patient had pain and went to the orthopaedic surgeon.The revision operation will take place on the (b)(6) 2016.

Manufacturer Narrative

An event regarding crack/fracture involving an exeter stem was reported.The event was confirmed.Method & results: device evaluation and results: a visual inspection was performed as part of the material analysis report.The parts were examined with the aid of a stereo microscope at magnifications up to 50x.Damage and fracture was observed on the surfaces of the returned device.Abrasion was observed at multiple locations on both of the fracture surfaces." the material analysis concluded that: "the device fractured in fatigue.Abrasion obscured the fracture surface at multiple locations.Eds was performed on the device with the base alloy being consistent with astm f1586.Debris was also observed on the fracture surface, consistent with the decontamination process.No material or manufacturing defects were observed on the surfaces examined." medical records received and evaluation: a review of the medical records by a clinical consultant concluded: "end of practical service life of a first generation polyethylene cup through ¿normal¿ wear further accelerated by suboptimal (by todays standards) type of cement less fixation and excessive anteversion has caused poly particulate debris induced osteolysis around the proximal part of the exeter stem ultimately leading to complete loss of bone support around the proximal two-thirds stem section with an overload condition and ultimately a fatigue fracture exactly at the level of peak overload." conclusions: a review by a clinical consultant concluded "suboptimal type of cement less fixation and excessive anteversion" ultimately resulted in the fatigue fracture.No evidence of a device related issue was noted during the clinical review, further to this a material analysis concluded that "no material or manufacturing defects were observed on the surfaces examined".No further investigation for this event is possible at this time.If additional information becomes available, this investigation will be reopened.

Event Description

It is reported that an implanted exeter stem broke.Update: exeter hipstem, implanted in 1997, fractured in (b)(6) 2015.No trauma involved.The fracture was noticed during an inspection.The patient had pain and went to the orthopaedic surgeon.The revision operation will take place on the (b)(6) 2016.

• Brand Name: UNKNOWN EXETER STEM
• 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: 5461501
• MDR Text Key: 39077847
• Report Number: 0002249697-2016-00581
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 02/01/2016

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?: Yes
• 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: 03/03/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/01/2016
• Initial Date FDA Received: 02/25/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/31/2016
• 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; Other; Required Intervention
• Patient Age: 83 YR