MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE (127 DEG) SIZE 4.5 ACCOLADE (127 DEG) SIZE 4.5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 6021-4535

Device Problems Material Deformation (2976); Material Integrity Problem (2978)

Patient Problems Fall (1848); Injury (2348); Joint Dislocation (2374)

Event Date 11/14/2016

Event Type  Injury  

Manufacturer Narrative

An event regarding dislocation as a result of trauma was reported.The event for dislocation could not be performed, however trunnion wear was confirmed.Device evaluation and results: visual, dimensional and functional analysis could not be performed as the device was not returned.However, an image of the stem was provided and review of the clinician indicated ¿evidence of bony on growth proximally and deformed and eroded trunnion.¿ medical records received and evaluation: a review of the medical records and provided undated x-rays by a clinical consultant indicated: ¿no clinical or past medical history, no dated serial x-rays, no revision operative reports, and no examination of the explanted components are available for review.Based upon the information available for review, no determination can be made regarding the cause of this clinical event.¿ device history review: 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 evidenced by the provided photo of the stem.The reported event stated that the patient fell which could have lead to the dislocation.However, a review of the medical records and provided undated x-rays by a clinical consultant indicated: ¿no clinical or past medical history, no dated serial x-rays, no revision operative reports, and no examination of the explanted components are available for review.Based upon the information available for review, no determination can be made regarding the cause of this clinical event.¿ no further investigation for this event is possible at this time.If additional information and/or return of the devices become available, this investigation will be reopened.

Event Description

Rep reported patient fell and dislocated right hip.Surgery also due to recall of femoral head 36+5 v40.

• Brand Name: ACCOLADE (127 DEG) SIZE 4.5 ACCOLADE (127 DEG) SIZE 4.5
• 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: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6363187
• MDR Text Key: 68464361
• Report Number: 0002249697-2017-00691
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121308
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/27/2017

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2012
• Device Catalogue Number: 6021-4535
• Device Lot Number: 22394904
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/30/2017
• Initial Date FDA Received: 02/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2007
• 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; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 85