MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE (127 DEG) SIZE 2.5 ACCOLADE (127 DEG) SIZE 2.5; IMPLANT

Catalog Number 6021-2530

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Purulent Discharge (1812); Pain (1994)

Event Date 11/30/2014

Event Type  Injury  

Event Description

Pt had a tha by dr (b)(6) pt came to er with groin pain, mri scan large access in pt hip capsule and into pt acetabular cavity, copious amounts of cream color liquid removed from this access, dr.Had to do a extended trochentaric osteotomy to remove the stem from pts femoral bone, burrs and a giggly saw helped remove stem, a tabular liner was removed a new was implanted to aid the use of zimmer cup cutter, cup was removed, dr.Used a antibiotic spacer by depuy to fix the problem temporality.

Manufacturer Narrative

Additional devices listed in this report: cat 6260-9-336 v40 cocr lfit head 36mm/+10 lot code vvjmma.Cat 502-11-62g trident hemispherical cluster hole shell lot code 22695001.Cat 663-00-38g trident x3 eccentric 0 degree 36mm id lot code 11wvp.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.It was noted that the devices are not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report.

Manufacturer Narrative

An event regarding infection involving an accolade stem was reported.The event was not confirmed.Method & results: -device evaluation and results: the device was not returned for analysis.-medical records received and evaluation: insufficient information was received.-device history review: all devices in the reported lot were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other events for the reported lot and sterile lot.Conclusions: the exact cause of the event could not be determined because insufficient information was received.Further information such as device return, pathology report, x-rays, primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.If additional information and/or the device become available, this investigation will be reopened.A capa trend analysis was conducted for the reported failure mode and concluded infection is a known possible adverse outcome of surgery and is beyond stryker's control.

Event Description

Pt had a tha by dr (b)(6).Pt came to er with groin pain, mri scan large access in pt hip capsule and into pt acetabular cavity, copious amounts of cream color liquid removed from this access, dr.Had to do a extended trochentaric osteotomy to remove the stem from pts femoral bone, burrs and a giggly saw helped remove stem, a tabular liner was removed a new was implanted to aid the use of zimmer cup cutter, cup was removed, dr.Used a antibiotic spacer by depuy to fix the problem temporality.

• Brand Name: ACCOLADE (127 DEG) SIZE 2.5 ACCOLADE (127 DEG) SIZE 2.5
• 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: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4354043
• MDR Text Key: 21241091
• Report Number: 0002249697-2014-04863
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 11/30/2014

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: 05/31/2012
• Device Catalogue Number: 6021-2530
• Device Lot Number: 22573303
• Other Device ID Number: STERILE LOT 0705CIRZ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2015
• Initial Date FDA Received: 12/22/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2007
• 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): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 116