MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE 132 SIZE 2.5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 6020-2530

Device Problems Corroded (1131); Metal Shedding Debris (1804); Loss of Osseointegration (2408)

Patient Problems Bone Fracture(s) (1870); Inflammation (1932); Injury (2348); Reaction (2414); Inadequate Osseointegration (2646)

Event Date 08/31/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

"periprosthetic fracture, when we opened the patient there was metallosis around the neck & head.Ball was still attached but clearly there had to be some micro motion".Update (b)(6) 2017: per operative report: right hip periprosthetic femur fracture with loose femoral stem.Patient revised to a combination of djo and stryker implants.

Manufacturer Narrative

An event regarding revision periprosthetic fracture leading to stem loosening and corrosion involving an accolade stem was reported.The event was confirmed.Device evaluation and results: material analysis was performed and concluded "adhered debris was observed on the stem trunnion and head taper.Damage consistent with explantation was observed on the head.Eds showed the stem was consistent astm f1813 alloy, the head was consistent with astm f1537 alloy, and the debris samples were consistent with the stem, head, and a corrosion product from the head in addition to biological material.No material or manufacturing defects were observed on the surfaces examined." medical records received and evaluation: a review of the medical records and x-rays by the consulting clinician indicated "multiple postoperative hazards are identified including loss of fixation of a cemented acetabular component, infection and periprosthetic fracture.The patient had medical history which included chronic vit d deficiency as well as fibromyalgia requiring the chronic use of steroids.As a result she undoubtedly had significant osteopenia putting her at risk for both early component loosening as well as fracture.In addition the chronic steroid use is immunosuppressive putting her at risk for infection.There is no evidence for defect in the implants or their manufacture." 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 have been no other similar events for the reported lot.Conclusions: the event for the corrosion was confirmed based on the material analysis report stating "the debris samples were consistent with the stem, head, and a corrosion product from the head in addition to biological material.No material or manufacturing defects were observed on the surfaces examined." a review of the medical records and x-rays by the consulting clinician indicated: "as a result she undoubtedly had significant osteopenia putting her at risk for both early component loosening as well as fracture.In addition the chronic steroid use is immunosuppressive putting her at risk for infection.There is no evidence for defect in the implants or their manufacture." if additional information becomes available, this investigation will be reopened.

Event Description

"periprosthetic fracture, when we opened the patient there was metallosis around the neck & head.Ball was still attached but clearly there had to be some micro motion".Update 09/19/2017: per operative report: right hip periprosthetic femur fracture with loose femoral stem.Patient revised to a combination of djo and stryker implants.

• Brand Name: ACCOLADE 132 SIZE 2.5
• 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: brian lauro ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6903169
• MDR Text Key: 87713273
• Report Number: 0002249697-2017-02882
• 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,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/28/2017

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: 01/06/2017
• Device Catalogue Number: 6020-2530
• Device Lot Number: 38690905
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/31/2017
• Initial Date FDA Received: 09/28/2017
• Supplement Dates Manufacturer Received: 10/31/2017
• Supplement Dates FDA Received: 11/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2012
• 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: 73 YR