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

Catalog Number 6260-9-236

Device Problems Material Separation (1562); Naturally Worn (2988)

Patient Problem No Code Available (3191)

Event Date 03/25/2014

Event Type  Injury  

Event Description

It was reported that there was a revision of a stem head and liner due to the fact that the head disassociated off the stem and trunnion was worn.

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Manufacturer Narrative

An event regarding disassociation between the femoral head and the stem involving a v40 cocr lfit head 36mm/+5 was reported.The disassociation was not confirmed.A material analysis confirmed no material or manufacturing defects were observed.A device history review confirmed all devices accepted into finished goods conformed to specification.A complaint history review confirmed no other similar events for the reported lot.The exact cause of the event could not be determined because of a lack of information.The wear on the trunnion was determined to be caused by movement between the femoral head taper and the female stem trunnion however how or when the locking mechanism failed was not able to be determined.Despite this information, the disassociation between the femoral head and stem could not be confirmed without further clinical information.No further investigation for this event is possible at this time.

Event Description

It was reported that there was a revision of a stem head and liner due to the fact that the head disassociated off the stem and trunnion was worn.

• 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: niku kasmai ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3761830
• MDR Text Key: 20297509
• Report Number: 0002249697-2014-01312
• Device Sequence Number: 1
• Product Code: JDI
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/25/2014

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: 05/31/2012
• Device Catalogue Number: 6260-9-236
• Device Lot Number: M7EMHD
• Other Device ID Number: STER. LOT MSH0705HH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/04/2014
• Initial Date FDA Received: 04/21/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2007
• 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: 82 YR