MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 36MM/+5; IMPLANT

Catalog Number 6260-9-236

Device Problems Material Separation (1562); Device Dislodged or Dislocated (2923); Naturally Worn (2988)

Patient Problems Pain (1994); Ambulation Difficulties (2544)

Event Date 02/01/2015

Event Type  Injury  

Event Description

The surgeon, mr (b)(6), reported via the sales rep, per-olaf brettmar, that the (b)(6), female patient arrived at the hospital emergency department on the (b)(6) complaining of pain and that she was unable to use her leg ever since she had felt a sharp pain in her left hip when she was bending down to dry her legs after getting out of the shower.The surgeon reported that the patient had undergone a primary left hip replacement for osteoarthritis on the (b)(6) 2008 where she had been implanted with an accolade stem and trident cup.It was further reported that the patient underwent a revision procedure on the (b)(6) whereby the surgeon discovered that the joint had dislocated, the femoral head had separated from the stem and the trunnion on the stem was heavily worn.The patient medical records show that the patient was revised with an exeter stem (with cerclage) ref.(b)(4), a v40 femoral head ref.(b)(4) and a trident x3 liner ref (b)(4).It is further reported that the patient is (b)(6).

Manufacturer Narrative

An event regarding disassociation involving an accolade stem and a metal head was reported.The event was confirmed.Method & results: the device was returned for evaluation.All surfaces of the trunnion exhibited wear from movement against the femoral head taper, with predominant material loss on the medial and laterals sides.No original machined surfaces remained on the sides of the trunnion.The material analysis report concluded that: movement between the femoral head taper and the femoral stem trunnion caused wear and material loss within the taper junction.Due to the degradation present on the taper and trunnion surfaces, it was not possible to evaluate the condition of the taper lock that permitted movement to occur.No material or manufacturing issues were observed on the device features evaluated.A review of the provided information by a clinical consultant confirmed the event but could not determine a root cause.Device history review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review indicated there have been no other events for the reported lot.Conclusions: the exact cause of the event could not be determined based on the information available.However, no material or manufacturing issues were observed on the device features evaluated.If further information becomes available, this investigation will be re-opened.

• Brand Name: V40 COCR LFIT HEAD 36MM/+5
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4858550
• MDR Text Key: 5806462
• Report Number: 0002249697-2015-01992
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/02/2015

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?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2013
• Device Catalogue Number: 6260-9-236
• Device Lot Number: 0V1MMD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/26/2015
• Initial Date FDA Received: 06/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2007
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Weight: 87