MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 4 ACCOLADE II BROACH; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 1020-5204

Device Problems Peeled/Delaminated (1454); Device Markings/Labelling Problem (2911)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/06/2018

Event Type  malfunction  

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.

Event Description

During operation, the operator found that the green marking of the broach was peeled off.The fragment was removed from the patient body.

Manufacturer Narrative

An event regarding crack/fracture involving an accolade broach was reported.The event was confirmed by product inspection.Method & results: product evaluation and results: visual inspection was performed as part of the material analysis report (mar), dated 14-mar-2018.The macroscopic fracture morphologies observed on the fracture surface of the neck indicator are consistent with a fracture due to multiple overload events.The mar report concluded: the neck indicator fractured in multiple overload events.Clinician review: not performed as patient factors did not contributed to the event findings.Product history review: a review of the product history review indicated the devices accepted into final stock with no reported discrepancies.Complaint history review: there has been no other event for the lot referenced.Conclusions: the reported event was confirmed as per material analysis performed on the returned product which concluded that the neck indicator fractured in multiple overload events.No identifiable material or manufacturing discrepancies were observed on the surfaces examined.No further investigation is required at this time.If the additional information will be received, this investigation will be reopened and re-evaluated.

Event Description

During operation, the operator found that the green marking of the broach was peeled off.The fragment was removed from the patient body.

• Brand Name: SIZE 4 ACCOLADE II BROACH
• 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: timothy rice ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7316955
• MDR Text Key: 101717118
• Report Number: 0002249697-2018-00640
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K153345
• 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: 05/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: 1020-5204
• Device Lot Number: 127919
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2015
• 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): Other