MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 28MM -4 V40 TAPER VIT HEAD; IMPLANT

Catalog Number 6260-5-028

Device Problem Fitting Problem (2183)

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

Event Date 05/02/2014

Event Type  malfunction  

Event Description

The operating department practitioner reported via the (b)(4) competent authority, the (b)(4), that during a primary total hip replacement procedure, it was found that the femoral head implant would not fit securely on the trunion neck of the femoral stem.

Manufacturer Narrative

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

Manufacturer Narrative

The event was not confirmed.The exact cause of the event could not be determined because the reported event could not be confirmed as the reported device was found to be dimensionally wthin specification and acceptable.The reported stem was not returned as it was implanted.

Event Description

The operating department practitioner reported via (b)(6) that during a primary total hip replacement procedure, it was found that the femoral head implant would not fit securely on the trunion neck of the femoral stem.

Manufacturer Narrative

An event regarding seating locking issue involving a 28mm -4 v40 taper vit head was reported.The event was confirmed.The returned device was dimensionally inspected per the inspection guide sheet and found to be within specification.No medical records were received for evaluation.Device history review indicated that all devices were manufactured and accepted into stock with no reported discrepancies.Complaint history review indicated that there have been no previously reported similar events for the reported lot number.The exact cause of the event could not be determined because the reported event could not be confirmed as the reported device was found to be dimensionally within specification and acceptable.

Event Description

The operating department practitioner reported via the (b)(4) competent authority, the mhra, that during a primary total hip replacement procedure, it was found that the femoral head implant would not fit securely on the trunnion neck of the femoral stem.

• Brand Name: 28MM -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 NJ 07430 NA
• Manufacturer Contact: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3846348
• MDR Text Key: 4656638
• Report Number: 0002249697-2014-02095
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K993601
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Nursing Assistant
• Type of Report: Initial,Followup,Followup
• Report Date: 05/13/2014

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: 12/31/2018
• Device Catalogue Number: 6260-5-028
• Device Lot Number: 45804105
• Other Device ID Number: STER. LOT 1312OCM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/17/2014
• Initial Date FDA Received: 06/03/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 09/18/2014; 07/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2013
• 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
• Patient Age: 61 YR