MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 40MM/+4; IMPLANT

Catalog Number 6260-9-240

Device Problems Metal Shedding Debris (1804); Insufficient Information (3190)

Patient Problems Complaint, Ill-Defined (2331); Injury (2348)

Event Date 08/14/2015

Event Type  Injury  

Manufacturer Narrative

Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.

Event Description

Surgeon revised patient's right accolade i hip due to pseudo tumor and metallosis.Surgeon revised head and liner only - stem remained implanted and was well fixed.

Manufacturer Narrative

The event could not be confirmed nor the root cause of the reported event determined due to the minimal information received.The device history review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated there have been no other similar events for the reported lot.

Event Description

Surgeon revised patient's right accolade i hip due to pseudo tumor and metallosis.Surgeon revised head and liner only - stem remained implanted and was well fixed.

• Brand Name: V40 COCR LFIT HEAD 40MM/+4
• 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: sandra spokane ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5070439
• MDR Text Key: 25542453
• Report Number: 0002249697-2015-02983
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061434
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 08/14/2015

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: 05/31/2016
• Device Catalogue Number: 6260-9-240
• Device Lot Number: MKHEAP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/11/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2011
• 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: 62 YR