MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE (127 DEG) SIZE 4.5 ACCOLADE (127 DEG) SIZE 4.5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 6021-4535

Device Problems Mechanical Problem (1384); Insufficient Information (3190)

Patient Problems Inflammation (1932); Injury (2348); Reaction (2414); Ambulation Difficulties (2544)

Event Date 01/18/2016

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.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

It was reported the patient was implanted with an lfit anatomic cocr v40 femoral head on his right hip on or about (b)(6) 2006 and was revised on (b)(6) 2016.It is further alleged that he suffered injuries as a result of implantation and explantation of the device at issue, and excessive levels of chromium and cobalt in his blood.

Manufacturer Narrative

Additional information: update to patient information, catalog and lot numbers, and update to executive summary.An event regarding disassociation involving an accolade stem that mated with a lfit v40 cocr head was reported. the event was not confirmed.    method & results:  device evaluation and results: not performed as product was not returned.Clinician review: a review of the provided medical records and/or x-rays by a clinical consultant indicated: "cannot confirm event, need additional information; primary operative reports, clinical and past medical history, serial dated x-rays and examination of explanted components." 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:  it has been confirmed that the mated lfit v40 cocr head has been identified to be within scope of nc and capa.Lot specific voluntary recall ra 2016-028 was initiated for the lfit v40 cocr heads within scope of nc and capa.If further information becomes available or the product is returned, this investigation will be re-opened.

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 his right hip on or about (b)(6) 2006 and was revised on (b)(6) 2016.It is further alleged that he suffered injuries as a result of implantation and explantation of the device at issue, device recall and excessive levels of chromium and cobalt in his blood.Update 03 feb 2020: the revision operative report notes that the patient was admitted with a dislocation where his trunnion disassociated from his femoral head.Intraoperatively when the proximal portion of the femur was exposed, it showed a penciled trunnion.

• Brand Name: ACCOLADE (127 DEG) SIZE 4.5 ACCOLADE (127 DEG) SIZE 4.5
• 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: 8518006
• MDR Text Key: 142051108
• Report Number: 0002249697-2019-01612
• 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: 03/03/2020

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: 04/30/2011
• Device Catalogue Number: 6021-4535
• Device Lot Number: 17352602
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/19/2019
• Initial Date FDA Received: 04/16/2019
• Supplement Dates Manufacturer Received: 02/04/2020
• Supplement Dates FDA Received: 03/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR