MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 6020-0540

Device Problems Degraded (1153); Fracture (1260); Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)

Patient Problems Bone Fracture(s) (1870); Pain (1994); Injury (2348)

Event Date 01/24/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The patient presented with severe posterior hip pain having had implanted a accolade tmzf stem approx.9 years ago with a mitch cup.Multifactorial issues led to the degeneration of the stem trunnion, resulting in a complete fracture of femoral stem neck, requiring revision.

Manufacturer Narrative

An event regarding a crack/fracture involving an accolade stem was reported.The event was confirmed.Method & results: -device evaluation and results: a mar was carried out by a material analysis engineer which concluded; [.]damage was observed on the accolade trunnion, consistent with an interaction with the head and shell.This damage was consistent with a result due to a loss of taper lock between the head taper and the stem trunnion.The trunnion fractured in overload.Eds showed stem was consistent with (b)(4).[.] -medical records received and evaluation: a review of the provided medical records by a clinical physician noted; [.] procedure-related factors: - component malposition although exact type cannot be determined due to limited x-ray information.Patient-related factors - obesity with (b)(6) as magnifying factor.Device-related factors: - none as also supported by mar findings.Diagnosis: - component malposition, possibly suboptimal cup inclination, has caused impingement between stem neck and cup rim with fatigue accumulation and ultimately a neck fracture.[.] -device history review: indicated that the specified lot was accepted into final stock with no reported discrepancies.-complaint history review: indicated that there have not been any other events for the specified lot.Conclusions: a mar by a material analysis engineer concluded; [.] damage was observed on the accolade trunnion, consistent with an interaction with the head and shell.This damage was consistent with a result due to a loss of taper lock between the head taper and the stem trunnion.The trunnion fractured in overload.Eds showed stem was consistent with (b)(4).[.] a review of the provided x-rays by a clinical consultant concluded; [.] component malposition, possibly suboptimal cup inclination, has caused impingement between stem neck and cup rim with fatigue accumulation and ultimately a neck fracture.[.] if further information becomes available this investigation will be re-opened.

Event Description

The patient presented with severe posterior hip pain having had implanted a accolade tmzf stem approx.9 years ago with a mitch cup.Multifactorial issues led to the degeneration of the stem trunnion, resulting in a complete fracture of femoral stem neck, requiring revision.

• Brand Name: ACCOLADE
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• 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: rita intorrella ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6350335
• MDR Text Key: 68053495
• Report Number: 0002249697-2017-00623
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K121308
• 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: 05/23/2017

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 Expiration Date: 10/31/2011
• Device Catalogue Number: 6020-0540
• Device Lot Number: 20296003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2017
• Initial Date FDA Received: 02/22/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2006
• 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: 68 YR
• Patient Weight: 104