MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 FEM HEAD ORTHINOX 28+4; IMPLANT

Catalog Number 6364-2-228

Device Problem Device Inoperable (1663)

Patient Problem Pain (1994)

Event Date 01/13/2010

Event Type  Injury  

Event Description

The customer reported that the patient required revision surgery due to device failure.The customer further reported that the patient presented with onset of pain in the thigh and buttock.Revision surgery was undertaken on (b)(6) 2010.

Manufacturer Narrative

Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.Not available.

Manufacturer Narrative

An event regarding crack/fracture involving an exeter stem was reported.Conclusion: based on the provided information, the product reported in this investigation did not contribute to the event.The patient was revised for a broken exeter stem and there is no allegation of failure against the metal head.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

The customer reported that the patient required revision surgery due to device failure.The customer further reported that the patient presented with onset of pain in the thigh and buttock.Revision surgery was undertaken on (b)(6) 2010.

• Brand Name: V40 FEM HEAD ORTHINOX 28+4
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK (MDR); ida industrial estate; carrigtwohill NA
• Manufacturer Contact: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4899391
• MDR Text Key: 6540056
• Report Number: 0002249697-2015-02238
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K121308
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,health professional,oth
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/02/2015

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: 04/30/2007
• Device Catalogue Number: 6364-2-228
• Device Lot Number: GA650420
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/11/2015
• Initial Date FDA Received: 07/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2002
• 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 Weight: 95