MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN V40 SLEEVE; HIP IMPLANT

Catalog Number UNK_JR

Device Problem Insufficient Information (3190)

Patient Problems Inflammation (1932); Injury (2348); Joint Dislocation (2374); Reaction (2414)

Event Date 03/16/2018

Event Type  Injury  

Manufacturer Narrative

If additional information is received, it will be provided in a supplemental report upon completion of the investigation.

Event Description

Revision surgery of left hip due to high chrome cobalt levels & recurrent dislocation.Implants removed on (b)(6) 2018.

Manufacturer Narrative

An event regarding elevated ion levels involving a sleeve was reported.The abnormal ion levels were confirmed by a clinician review of the provided pathology report.Altr was not confirmed.The sleeve was returned in the ceramic head and could not be removed.Visual inspection of the returned device by the clinician revealed photographs of implants consistent with those removed were reviewed.No gross irregularities other than those related to explantation were seen.Dimensional inspection: not performed, no allegations relating to device dimensions.Functional inspection: not performed because the event is related to in-vivo performance and therefore functionality could not be duplicated.Material analysis: not performed as this event does not relate to material integrity.A review of the provided medical records by a clinical consultant indicated: patient underwent a primary left metal on metal tha on (b)(6) 2005 utilizing a accolade cementless stem with a 46 mm diameter ¿birmingham ¿ modular head mated with a 54 mm diameter ha coated ¿birmingham¿ dysplasia cup.This tha underwent revision on (b)(6) 2012.At that time the birmingham metal head and cup were removed and replaced with a 59 mm diameter ha coated stryker multihole cup and a 32 mm +0 delta ceramic femoral head.The accolade stem was left in place.During the surgery the abductor tendons were noted to be failing and required reattachment to the proximal femur.Excised synovium was sent for pathology with an expectation that it would show metal synovitis.Laboratory studies obtained prior to the revision on (b)(6) 2011 and (b)(6) 2012 both showed significantly elevated serum cobalt and chromium levels.Cobalt and chromium levels were retested 14 months after the revision surgery and still remained significantly elevated.Titanium levels tested at the same time were within normal limits.A second revision surgery with explantation of the accolade stem, cup liner and head was performed in (b)(6) of 2018.Photographs of implants consistent with those removed were reviewed.No gross irregukarities other than those related to explantation were seen.There is metallic striping on the ceramic head consistent with metal transfer.This may be related to recurrent dislocation.Undated lateral let tha xray shows evidence of peri-implant demineralization.The primary harm involved is elevated cobalt and chromium levels related to a primary tha using a stryker tmzf stem and another manufacturers metal on metal cobalt/chrome head and liner.Limited information was available for review however laboratory values for cobalt and chromium post index tha and post revision tha were significantly elevated and the brief description in the revision operative note regarding the abductor tendon degeneration is consistent with metallosis.Titanium levels drawn after revision to all stryker implants remained normal.No information regarding the (b)(6) 2018 was available.There is no evidence for defect in the tmzf accolade stem implants or their manufacture.The root cause of these failures leading to revision cannot be determined as insufficient information was available.Device history review: not performed as device lot is unknown.Complaint history review: not performed as device details are unknown.The exact cause of the event could not be determined because insufficient information was provided.Additional information is needed to fully investigate the event.If further information becomes available this investigation will be re-opened.

Event Description

Revision surgery of left hip due to high chrome cobalt levels & recurrent dislocation.Implants removed on (b)(6) 2018.

• Brand Name: UNKNOWN V40 SLEEVE
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7422147
• MDR Text Key: 105178808
• Report Number: 0002249697-2018-01092
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 07/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_JR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2018
• Date Manufacturer Received: 06/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR