MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN V40 TRUNNION STEM; HIP IMPLANT

Catalog Number UNK_REC

Device Problem Material Integrity Problem (2978)

Patient Problem Reaction (2414)

Event Date 12/01/2016

Event Type  Injury  

Manufacturer Narrative

Requests have been made to obtain more specific details from the initial reporter.Should more specific details be provided, additional reports and follow up information will be submitted.Not available.

Event Description

Per customer "many thanks for the recent urgent field safety notice for the lfit head.We have recently discussed this at one of our consultant meetings here.Myself and quite a few of my hip colleagues locally have significant concerns regarding the lfit heads and also the v40 trunnion.We are now seeing a lot of patients with metallosis and alval secondary to trunnionosis.The urgent field safety notice suggests it is 36 +5 heads and above, however, i think this is misleading.I am seeing the lfit heads fail in 32 minus all the way through to the plus range and also in the 36 minus heads 0 and plus.As such, unfortunately, this is only the tip of the iceberg and the failure is the lfit heads across the range particularly 32 and 36.There are very few 40 and 44mm out there but i think the 32 and the 36 should certainly be included.".

• Brand Name: UNKNOWN V40 TRUNNION STEM
• Type of Device: HIP 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: sarah smelko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6260809
• MDR Text Key: 65102272
• Report Number: 0002249697-2017-00278
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: GB
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/18/2017

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 Catalogue Number: UNK_REC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2016
• Initial Date FDA Received: 01/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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