MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 32MM -4 V40 TAPER VIT HEAD; IMPLANT

Catalog Number 6260-5-032

Device Problem Component Incompatible (1108)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/10/2014

Event Type  malfunction  

Event Description

It was reported that the taper of head was not matching to a stem.Engraving of head was correct but taper hole of head was bigger than a stem.Unfortunately there were no spare, so dr used different neck length (+-0mm) product instead of this product (-4mm).

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Manufacturer Narrative

An event regarding a head taper that was too big for the stem trunnion involving a v40 metal head was reported.The event was not confirmed.Method & results: -device evaluation and results: the device was dimensionally within specification and functionally acceptable.The reported event could not be replicated.Visual inspection: the v40 head was returned in its original packaging.The ifu and implant stickers were enclosed in the box.The head was unremarkable.-medical records received and evaluation: no medical records or x-rays were made available for evaluation.-device history review: review of the device history records indicates that all devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other events for this lot.Conclusions: the reported event could not be replicated and the device is dimensionally within specification.The investigation concluded that the reported event was caused by user factors.

Event Description

It was reported that the taper of head was not matching to a stem.Engraving of head was correct but taper hole of head was bigger than a stem.Unfortunately there were no spare so dr.Used different neck length (+-0mm) product instead of this product (-4mm).

• Brand Name: 32MM -4 V40 TAPER VIT HEAD
• Type of Device: IMPLANT
• 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: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3969952
• MDR Text Key: 4626292
• Report Number: 0002249697-2014-02928
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K993601
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: 6260-5-032
• Device Lot Number: 46972001
• Other Device ID Number: STER. LOT 1602SCM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/29/2014
• Initial Date FDA Received: 07/31/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/30/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2014
• 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