MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE (127 DEG) SIZE 3.5 ACCOLADE (127 DEG) SIZE 3.5; IMPLANT

Catalog Number 6021-3535

Device Problems Device Dislodged or Dislocated (2923); Naturally Worn (2988)

Patient Problem Pain (1994)

Event Date 02/01/2015

Event Type  Injury  

Event Description

The surgeon reported via the sales rep, that the (b)(6) female patient arrived at the hospital emergency department on (b)(6) complaining of pain and that she was unable to use her leg ever since she had felt a sharp pain in her left hip when she was bending down to dry her legs after getting out of the shower.The surgeon reported that the patient had undergone a primary left hip replacement for osteoarthritis on (b)(6) 2008 where she had been implanted with an accolade stem and trident cup.It was further reported that the patient underwent a revision procedure on (b)(6) whereby the surgeon discovered that the joint had dislocated, the femoral head had separated from the stem and the trunnion on the stem was heavily worn.The patient medical records show that the patient was revised with an exeter stem (with cerclage) ref (b)(4), a v40 femoral head ref (b)(4) and a trident x3 liner ref (b)(4).It is further reported that the patient is (b)(6).

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Manufacturer Narrative

An event regarding disassociation involving an accolade stem and a metal head was reported.The event was confirmed.Method & results: the device was returned for evaluation.All surfaces of the trunnion exhibited wear from movement against the femoral head taper, with predominant material loss on the medial and laterals sides.No original machined surfaces remained on the sides of the trunnion.The material analysis report concluded that: movement between the femoral head taper and the femoral stem trunnion caused wear and material loss within the taper junction.Due to the degradation present on the taper and trunnion surfaces, it was not possible to evaluate the condition of the taper lock that permitted movement to occur.No material or manufacturing issues were observed on the device features evaluated.A review of the provided information by a clinical consultant confirmed the event but could not determine a root cause.The device history review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review indicated there have been no other events for the reported lot.Conclusions: the exact cause of the event could not be determined based on the information available.However, no material or manufacturing issues were observed on the device features evaluated.If further information becomes available, this investigation will be re-opened.

Event Description

The surgeon reported via the sales rep, that the (b)(6) year old, female patient arrived at the hospital emergency department on the (b)(6) complaining of pain and that she was unable to use her leg ever since she had felt a sharp pain in her left hip when she was bending down to dry her legs after getting out of the shower.The surgeon reported that the patient had undergone a primary left hip replacement for osteoarthritis on the (b)(6) 2008 where she had been implanted with an accolade stem and trident cup.It was further reported that the patient underwent a revision procedure on the (b)(6) whereby the surgeon discovered that the joint had dislocated, the femoral head had separated from the stem and the trunnion on the stem was heavily worn.The patient medical records show that the patient was revised with an exeter stem (with cerclage) ref.0580-1-501, a v40 femoral head ref.6364-2-036 and a trident x3 liner ref 623-10-36e.(b)(6).

• Brand Name: ACCOLADE (127 DEG) SIZE 3.5 ACCOLADE (127 DEG) SIZE 3.5
• Type of Device: IMPLANT
• 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 navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4551470
• MDR Text Key: 5460047
• Report Number: 0002249697-2015-00486
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K994366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2013
• Device Catalogue Number: 6021-3535
• Device Lot Number: 25338502
• Other Device ID Number: STER LOT: 0801JMZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2008
• 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
• Patient Age: 62 YR
• Patient Weight: 87