MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE (127 DEG) SIZE 3.5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 6021-3535

Device Problems Material Separation (1562); Metal Shedding Debris (1804)

Patient Problems Complaint, Ill-Defined (2331); Reaction (2414); No Code Available (3191)

Event Date 09/23/2016

Event Type  Injury  

Manufacturer Narrative

No additional information is available at this time due to ongoing litigation.Should additional information become available, it will be provided in a supplemental report.

Event Description

It was reported through the filing of a lawsuit that allegedly the patient underwent a left total hip arthroplasty revision (b)(6) 2015.It is further alleged that "during the procedure, the surgeon encountered significant damage caused by metal debris, including adverse local tissue reaction, a pseudotumor, more than 50% loss of abductor muscles, and dissociation of the femoral stem and head".

Manufacturer Narrative

An event regarding disassociation and altr involving a accolade stem was reported.Neither disassociation or altr were confirmed.Method and results: device evaluation and results: device inspection could not be performed as the device was not returned.Medical records received and evaluation: not performed as no medical records were provided for review with a clinical consultant.Device history review: all devices in the reported lot were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there has been no other event for the lot referenced.Conclusions: the exact cause of the event could not be determined due to a lack of information.Further information such as medical records, x-rays, return of device, patient history and follow up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If additional information becomes available, this investigation will be reopened.

Event Description

It was reported through the filing of a lawsuit that allegedly the patient underwent a left total hip arthroplasty revision (b)(6) 2015.It is further alleged that "during the procedure, the surgeon encountered significant damage caused by metal debris, including adverse local tissue reaction, a pseudotumor, more than 50% loss of abductor muscles, and dissociation of the femoral stem and head".

• Brand Name: ACCOLADE (127 DEG) SIZE 3.5
• 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: 6046666
• MDR Text Key: 58046864
• Report Number: 0002249697-2016-03305
• 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: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/22/2016

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: 11/30/2010
• Device Catalogue Number: 6021-3535
• Device Lot Number: 16007603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/23/2016
• Initial Date FDA Received: 10/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2005
• 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): Required Intervention