MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 7 ACCOLADE II BROACH; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 1020-5207

Device Problems Break (1069); Fracture (1260); Material Integrity Problem (2978); Insufficient Information (3190)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 10/05/2016

Event Type  malfunction  

Manufacturer Narrative

Additional information has been requested and if received, will be provided in the supplemental report.Not returned to manufacturer.

Event Description

It was reported that the item broke at the socket.

Manufacturer Narrative

An event regarding crack/fracture involving a accolade broach was reported.The event was not confirmed.Method & results: -device evaluation and results: a visual, functional and dimensional inspection could not be performed as the device was not returned.-medical records received and evaluation: not performed as medical records were not received and patient factors didn't contribute to the event.-device history review: review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other events for this lot.Conclusions: the event could not be confirmed nor the root cause could be determined because the device was not returned for evaluation and insufficient medical information was provided.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.

Event Description

It was reported that the item broke at the socket.

Manufacturer Narrative

Product available to stryker/returned to manufacturer on an event regarding crack/fracture involving a accolade broach was reported.The event was confirmed.The device was returned in used condition.Visual inspection of the returned device shows that it was fractured at the trunnion.Review of returned device by material analysis engineer indicated "the locking mechanism fractured in overload.No material or manufacturing defects were observed on the surfaces examined.¿ medical records received and evaluation: not performed as patient factors did not contribute to the event.Device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.Complaint history review: there has been no other event for the lot referenced.The event was confirmed as per visual inspection of the returned device which shows that device was fractured at the trunnion.The returned device was consulted with material analysis engineer who indicated that the locking mechanism fractured in overload.No material or manufacturing defects were observed on the surfaces examined.No further investigation is possible at this time.If the additional information will be received, this investigation will be reopened and re-evaluated.

Event Description

It was reported that the item broke at the socket.

• Brand Name: SIZE 7 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: rita intorrella ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6067587
• MDR Text Key: 59039894
• Report Number: 0002249697-2016-03417
• 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: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1020-5207
• Device Lot Number: B6HEG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/05/2016
• Initial Date FDA Received: 10/31/2016
• Supplement Dates Manufacturer Received: Not provided; 06/14/2017
• Supplement Dates FDA Received: 01/19/2017; 07/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other