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

Catalog Number UNK_SHC

Device Problems Degraded (1153); Loss of Osseointegration (2408); Material Deformation (2976)

Patient Problems Injury (2348); Inadequate Osseointegration (2646)

Event Date 12/14/2017

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.

Event Description

It was reported that patient's hip (side not reported) was revised due to a loose cup.Intra-operatively, surgeon reported evidence of trunnionosis.

Event Description

It was reported that patient's hip (side not reported) was revised due to a loose cup.Intra-operatively, surgeon reported evidence of trunnionosis.

Manufacturer Narrative

An event regarding trunnionosis involving an unknown accolade stem was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as the device was not returned.Medical records received and evaluation: a review of the returned medical information was performed by a clinical consultant who concluded the following: [.]procedure-related factors: component malposition of undetermined type, most likely the cup.Patient-related factors - no info.Device-related factors: - none.Diagnosis: component malposition of undetermined type due to lack of imaging info has contributed to impingement with an overload condition in the arthroplasty with cup loosening, a local osteolytic fracture and secondary corrosion in the femoral head taper junction requiring revision.Device history review: could not be performed as the lot details were not provided.Complaint history review: could not be performed as the lot details were not provided.Conclusions: a medical review concluded the following: [.] diagnosis: component malposition of undetermined type due to lack of imaging info has contributed to impingement with an overload condition in the arthroplasty with cup loosening, a local osteolytic fracture and secondary corrosion in the femoral head taper junction requiring revision.No further investigation for this event is possible at this time as no devices and insufficient information was received by stryker orthopaedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: UNKNOWN ACCOLADE TMZF STEM
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7181689
• MDR Text Key: 96943849
• Report Number: 0002249697-2018-00130
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 02/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2018
• 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?: No
• Date Manufacturer Received: 01/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 78 YR