MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 36MM/+5; HIP JOINT FEMORAL (HEMI-HIP) METALLIC CEMENTED OR UNCEMENTED PROSTHESIS.

Catalog Number 6260-9-236

Device Problems Detachment Of Device Component (1104); Material Separation (1562); Naturally Worn (2988)

Patient Problem No Code Available (3191)

Event Date 04/02/2014

Event Type  Injury  

Event Description

The femoral head disassociated off an accolade stem.The surgeon commented on trunnion wear and proceeded to a fully coated ha stem.

Manufacturer Narrative

The catalog number and lot code were not provided.The device was reported as an unknown 36mm +5 femoral head.Additional information has been requested and if received, will be provided in the supplemental report.

Manufacturer Narrative

An event regarding dissociation of head involving a 36mm +5 femoral head was reported.The event was confirmed.Method & results: device evaluation could not be performed as no items associated with the event were returned or made available for identification or evaluation.There are photographs on a provided surgeon's journal, that shows photographs of the explanted devices, the photo that shows a metal head with lot id 21297003 shows some debris and black stains.There is damage in the rim of the trunnion hole.Medical records received and evaluation: no patient medical records were available for review.Device history review : records indicate all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: a review of the complaint databases concluded that there have been no other events for the lot referenced.Conclusions: the event was confirmed from the photographs provided of the disassociation of the head from the stem, unfortunately the root cause could not be determined because the devices were not returned for evaluation and insufficient medical information was provided.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.

Event Description

The femoral head disassociated off an accolade stem.The surgeon commented on trunnion wear and proceeded to a fully coated ha stem.

• Brand Name: V40 COCR LFIT HEAD 36MM/+5
• Type of Device: HIP JOINT FEMORAL (HEMI-HIP) METALLIC CEMENTED OR UNCEMENTED PROSTHESIS.
• 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: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3764491
• MDR Text Key: 4548039
• Report Number: 0002249697-2014-01477
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,health professional,oth
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/02/2014

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: 02/29/2012
• Device Catalogue Number: 6260-9-236
• Device Lot Number: 21297003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/02/2014
• Initial Date FDA Received: 04/22/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/25/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2007
• 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): Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 132