MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 36MM/+5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 6260-9-236

Device Problems Detachment Of Device Component (1104); Disassembly (1168); Device Inoperable (1663)

Patient Problems Failure of Implant (1924); Injury (2348)

Event Date 06/06/2014

Event Type  Injury  

Event Description

A trunnion failure was reported, head disassociated.

Manufacturer Narrative

Catalog number is unknown at this time.The device was reported as an unknown head.Additional information has been requested and if received, will be provided in the supplemental report.Not returned.

Manufacturer Narrative

Reported event: an event regarding disassociation involving a v40 cocr head was reported.The event was not confirmed.Method & results: -device evaluation and results: device inspection could not be performed as the device was not returned.-medical records received and evaluation: not performed as no medical records were provided for review with a clinical consultant.-device history review: all devices in the reported lot were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there has been no other similar events for the lot referenced.Conclusions: the exact cause of the event could not be determined due to a lack of information.Further information such as medical records, x-rays, patient history and follow up notes are needed to complete the investigation for determining root cause.The reported event is under the scope of (b)(4).

Event Description

A trunnion failure was reported, head disassociated.

• Brand Name: V40 COCR LFIT HEAD 36MM/+5
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• 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: 4583145
• MDR Text Key: 19995523
• Report Number: 0002249697-2015-00629
• 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,health professional,oth
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 02/11/2015

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: 06/30/2011
• Device Catalogue Number: 6260-9-236
• Device Lot Number: EXAMKA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/11/2015
• Initial Date FDA Received: 03/09/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2006
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 2249697-08/29/2016-007R
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention