MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 3 ACCOLADE II 127 DEG; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 6721-0330

Device Problems Metal Shedding Debris (1804); Naturally Worn (2988); Insufficient Information (3190)

Patient Problems Cyst(s) (1800); Pain (1994); Tissue Damage (2104); Discomfort (2330); Complaint, Ill-Defined (2331); Toxicity (2333); Injury (2348); Peroneal Nerve Palsy (2362); Ambulation Difficulties (2544); Limited Mobility Of The Implanted Joint (2671)

Event Date 12/27/2016

Event Type  Injury  

Manufacturer Narrative

The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.Not available.

Event Description

It was reported by the patient's attorney as a result of a legal claim that allegedly following the implantation on (b)(6) 2012 the patient suffered from left hip pain, discomfort, immobility etc.And was revised on (b)(6) 2016.It is further alleged during the revision the surgeon noted "black staining in the soft tissues and thick gelatinous joint fluid.Some superficial notching in the superior posterior aspect of the femoral component back region."the preoperative diagnosis was "left hip high output of wear, resulting in development of cyst compressing sciatic nerve" and the postoperative diagnosis was "metallosis due to impingement of the titanium femoral component with the rim of the cobalt chrome acteabular component resulting in increased development of joint fluid and development of the cyst".

Manufacturer Narrative

An event regarding metallosis (altr) and impingment (rom issue) involving an accolade stem was reported.The events were not confirmed.Method and results: -device evaluation and results: not performed as the reported device was not returned for evaluation.-medical records received and evaluation: a medical review was not performed because no medical information was provided.-device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: review indicated there have been no other similar events for the reported lot.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Additional information, including histopathology, operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.Product surveillance will continue to monitor for trends.

Event Description

It was reported by the patient's attorney as a result of a legal claim that allegedly following the implantation on (b)(6) 2012 the patient suffered from left hip pain, discomfort, immobility etc.And was revised on (b)(6) 2016.It is further alleged during the revision the surgeon noted "black staining in the soft tissues and thick gelatinous joint fluid.Some superficial notching in the superior posterior aspect of the femoral component back region."the preoperative diagnosis was "left hip high output of wear, resulting in development of cyst compressing sciatic nerve" and the postoperative diagnosis was "metallosis due to impingement of the titanium femoral component with the rim of the cobalt chrome acetabular component resulting in increased development of joint fluid and development of the cyst".

• Brand Name: SIZE 3 ACCOLADE II 127 DEG
• 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: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6271233
• MDR Text Key: 65537305
• Report Number: 0002249697-2017-00290
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143085
• 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: 03/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Catalogue Number: 6721-0330
• Device Lot Number: 39340501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2012
• 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: 47 YR