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

Catalog Number 6021-3535

Device Problem Insufficient Information (3190)

Patient Problems Inflammation (1932); Injury (2348); Reaction (2414); Metal Related Pathology (4530)

Event Date 01/18/2019

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.

Event Description

It was reported through the filing of a lawsuit that allegedly the patient was implanted with an lfit anatomic cocr v40 femoral head on her right hip on or about (b)(6) 2007 and was revised on (b)(6) 2019.It is further alleged that she suffered injuries as a result of implantation and explantation of the device(s) at issue and excessive levels of chromium and cobalt in her blood.

Manufacturer Narrative

Reported event: an event regarding abnormal ion level involving an accolade stem was reported.The event was not confirmed.Method & results:  -device evaluation and results: not performed as product remained implanted -clinician review: no medical records were received for review with a clinical consultant.   device history review: all devices 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.  conclusion: the event was not confirmed as insufficient information was provided.Further information such as device return, pre and post operative x-rays, operative reports as well as patient history and follow up notes are required to complete the investigation for determining a root cause.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

It was reported through the filing of a lawsuit that allegedly the patient was implanted with an lfit anatomic cocr v40 femoral head on her right hip on or about (b)(6) 2007 and was revised on (b)(6), 2019.It is further alleged that she suffered injuries as a result of implantation and explantation of the device(s) at issue and excessive levels of chromium and cobalt in her blood.

• Brand Name: ACCOLADE (127 DEG) SIZE 3.5 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
• MDR Report Key: 10475778
• MDR Text Key: 205086580
• Report Number: 0002249697-2020-01769
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K121308
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 02/24/2021

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: 09/30/2011
• Device Catalogue Number: 6021-3535
• Device Lot Number: 20186003
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/06/2020
• Initial Date FDA Received: 09/01/2020
• Supplement Dates Manufacturer Received: 01/28/2021
• Supplement Dates FDA Received: 02/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 56 YR