MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE TMZF HIP STEM #3; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 6020-0335

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

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

Event Date 04/20/2015

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.Device not available.

Event Description

This pi is for the right hip.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) 2015.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.

Event Description

This pi is for the right hip: 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) 2015.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.Update 22-jan-2020: as operative report provided, patient was revised due to disassociation.

Manufacturer Narrative

Additional information: update to executive summary, update to lot and catalog numbers, update to patient information.An event regarding disassociation involving a lfit v40 cocr head that was mated with an accolade stem 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 confirmed that the mated metal head is within scope of nc and capa.Lot specific voluntary recall was initiated for the lfit v40 cocr heads within scope of nc and capa.The exact cause of the event could not be determined because insufficient information was provided. additional information including primary operative reports, clinical and past medical history, serial dated x-rays and examination of explanted are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

• Brand Name: ACCOLADE TMZF HIP STEM #3
• 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: 8517929
• MDR Text Key: 142046793
• Report Number: 0002249697-2019-01606
• 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: 03/02/2020

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: 09/30/2010
• Device Catalogue Number: 6020-0335
• Device Lot Number: 14739901
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/19/2019
• Initial Date FDA Received: 04/16/2019
• Supplement Dates Manufacturer Received: 02/03/2020
• Supplement Dates FDA Received: 03/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR