MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 32MM +4 LFIT V40 HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 6260-9-232

Device Problems Detachment Of Device Component (1104); Entrapment of Device (1212); Insufficient Information (3190)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/29/2015

Event Type  malfunction  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device remains implanted.Additional information was requested and if it becomes available will be submitted in a supplemental report.Remains implanted.

Event Description

Sus voluntary event report # mw5045032: during left total hip arthroplasty surgery, the plastic trial femoral head came dislodged and went into the wound and could not be found.The surgical wound was searched extensively without finding the plastic, none radiopaque object (32mm plastic ball), the decision was made by the surgeon and operating room team to leave the foreign body inside the patient and the hip surgery was completed.A post operative ct scan noted the retained femoral head in the region of the left gluteus medius muscle.The patient was discharged from the hospital with out plans to remove the plastic piece.

Manufacturer Narrative

An event regarding intraoperative issues trialing involving a metal head was reported.The event was not confirmed.Method & results: device evaluation and results: the device was not returned for evaluation.Medical records received and evaluation: insufficient information was received for review with a clinical consultant.Device history review indicated all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review indicated there have been no other similar events for the reported lot.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Additional information, including event clarification, operative reports, x-rays, patient history, progress notes is needed to fully investigate the event.If further information and or device becomes available, this investigation will be re-opened.

Event Description

Sus voluntary event report # mw5045032: during left total hip arthroplasty surgery, the plastic trial femoral head came dislodged and went into the wound and could not be found.The surgical wound was searched extensively without finding the plastic, none radiopaque object (32mm plastic ball), the decision was made by the surgeon and operating room team to leave the foreign body inside the patient and the hip surgery was completed.A post operative ct scan noted the retained femoral head in the region of the left gluteus medius muscle.The patient was discharged from the hospital with out plans to remove the plastic piece.

• Brand Name: 32MM +4 LFIT V40 HEAD
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• 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: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5226525
• MDR Text Key: 31573265
• Report Number: 0002249697-2015-03748
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121308
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/20/2015

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: 6260-9-232
• Device Lot Number: 51183106
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/20/2015
• Initial Date FDA Received: 11/16/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2015
• 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): Other