MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 36MM/-5; HIP JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS.

Catalog Number 6260-9-036

Device Problem Material Integrity Problem (2978)

Patient Problem Reaction (2414)

Event Date 06/01/2015

Event Type  Injury  

Manufacturer Narrative

The information in this report was provided by stryker orthopaedics legal affairs.No additional information is available at this time due to ongoing litigation.Based on the limited information provided, the event could not be confirmed and the cause could not be determined.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Legal case.

Event Description

Patient called legal on (b)(6) 2016 at the direction the surgeon.He underwent primary right hip arthroplasty five years ago with an accolade tmzf stem.It is alleged that blood test performed in 2015 indicated high cobalt levels.The patient had an aspiration and a partial revision was performed in (b)(6) 2015.The surgeon told the patient that he had "extensive corrosion at the head neck junction.".

Event Description

Patient called legal on (b)(6), 2016 at the direction the surgeon.He underwent primary right hip arthroplasty five years ago with an accolade tmzf stem.It is alleged that blood test performed in 2015 indicated high cobalt levels.The patient had an aspiration and a partial revision was performed in (b)(6) of 2015.The surgeon told the patient that he had "extensive corrosion at the head neck junction.".

Manufacturer Narrative

An event regarding corrosion involving a metal head was reported.The event was not confirmed by medical review.Method & results: -product evaluation and results: visual, dimensional, functional inspection, and material analysis were not performed as the item was not returned.-clinician review: a review of the provided medical records and x-rays by a clinical consultant revealed: ¿there is no examination of the explanted head and no imaging or histopathology confirming the diagnosis of altr or trunnionosis as a source of clinical complaints related to the right total hip arthroplasty.The nonspecific histologic description of the soft tissues from the right total hip arthroplasty revision was consistent with the changes one month after a hip aspiration/arthrogram performance.Some dark material within the femoral head/trunnion junction after five years in situ is not diagnostic of pathologic trunnionosis.Slight elevated serum cobalt in a patient with long-standing bilateral total hip arthroplasties, including a modular stem in situ for twenty years, is not unexpected.Ion levels noted from joint aspiration fluid are neither diagnostic nor related to any none base levels.The fact that the trunnion after cleaning was described as "well suited for reuse!! further suggests that significant trunnion involvement was not a factor in this clinical situation.¿ -product history review: review of the product history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other events for this lot.Conclusions: the reported event of corrosion was not confirmed.According to the medical review the clinician stated that there was not enough evidence to confirm the alleged diagnosis of altr, trunnionosis or corrosion.It was noted that there was a slight elevation in the cobalt levels but with bilateral hip arthroplasties and devices implanted in the patient for approximately twenty years is not unexpected.It was also noted that the stem was left implanted in the patient and the trunnion cleaned.Based on this information the stem was well fixed and the trunnion was not an issue.Lot specific voluntary recall was initiated for the lfit v40 cocr heads within scope of a capa.The investigation revealed that only specific catalog numbers and specific lots are impacted by the regulatory action and that the affected lots were manufactured on or before march 4, 2011.The root cause analysis identified a process related anomaly as to the affected sizes and lots.The affected product has all been implanted and/or expired.

• Brand Name: V40 COCR LFIT HEAD 36MM/-5
• Type of Device: HIP JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS.
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 5442660
• MDR Text Key: 38411401
• Report Number: 0002249697-2016-00470
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: K173499
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 08/21/2018

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: 02/28/2015
• Device Catalogue Number: 6260-9-036
• Device Lot Number: MJA357
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/22/2016
• Initial Date FDA Received: 02/17/2016
• Supplement Dates Manufacturer Received: 07/24/2018
• Supplement Dates FDA Received: 08/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 2249697-05/07/2018-003R
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention