MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 32MM +8 LFIT V40 HEAD; IMPLANT

Catalog Number 6260-9-332

Device Problem Detachment Of Device Component (1104)

Patient Problem No Information (3190)

Event Date 09/24/2014

Event Type  Injury  

Event Description

Patient presented with total hip where the femoral head was disassociated from the femoral stem.The implants listed were removed and the doctor proceeded to a restoration modular stem.No other information per hospital protocol.It was a right hip.

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Additional information was requested and if it becomes available, the evaluation summary will be submitted in a supplemental report.Not returned.

Manufacturer Narrative

The patient is (b)(6) in height.An event regarding disassociation involving a metal head and an accolade stem was reported.The event was not confirmed.Medical records received and evaluation: insufficient information was received for review with a clinical consultant.Device history review: all devices in the reported lot were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for the reported lot.Conclusions: the exact cause of the event could not be determined because insufficient information was received.Further information such as device return, x-rays, primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.

Event Description

Patient presented with total hip where the femoral head was disassociated from the femoral stem.The implants listed were removed and the doctor proceeded to a restoration modular stem.No other information per hospital protocol.It was a right hip.

• Brand Name: 32MM +8 LFIT V40 HEAD
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4194741
• MDR Text Key: 4980930
• Report Number: 0002249697-2014-03933
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K010757
• 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: 09/24/2014

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: 08/31/2010
• Device Catalogue Number: 6260-9-332
• Device Lot Number: 14190701
• Other Device ID Number: STERILE LOT 0508LCH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2014
• Initial Date FDA Received: 10/22/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/20/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2005
• 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: 66 YR
• Patient Weight: 80