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

Catalog Number 6260-5-132

Device Problem Device Packaging Compromised (2916)

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

Event Date 05/26/2014

Event Type  malfunction  

Event Description

The sales rep, has reported on behalf of the customer that a v40 head has been received and the package allegedly looks moist and used.The customer questioned if the product is sterile.The sales rep reported that another v40 head was used.

Manufacturer Narrative

The lot code provided, 4711505, appears to be invalid.The actual lot will be confirmed upon receipt of the device and the updated information will be submitted in a supplemental report upon completion of the investigation.

Manufacturer Narrative

An event regarding a bulge on the inner tyvek involving packaging for a metal head was reported.The event was confirmed.Device evaluation and results: the device and packaging were returned.The shrink wrap was not returned.The outer box was opened and unremarkable.The outer (b)(6) had been peeled back from the inner blister on 3 sides and there was evidence of a complete seal.The inner (b)(6) and blister were still sealed.There was a slight bulge observed on the centre of the inner (b)(6).The event was discussed with the packaging cell, it was determined that the reported event did not represent a non-conformance.Device history review: all devices in the reported lot were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for the reported lot.Conclusions: the investigation concluded that the observed bulge on the (b)(6) was not a non-conformance.

Event Description

The sales rep, has reported on behalf of the customer that a v40 head has been received and the package allegedly looks moist and used.The customer questioned if the product is sterile.The sales rep reported that another v40 head was used.

• Brand Name: 32MM STD 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: 3875229
• MDR Text Key: 16803423
• Report Number: 0002249697-2014-02301
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K993601
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/26/2014

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: 03/31/2019
• Device Catalogue Number: 6260-5-132
• Device Lot Number: 4711505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/13/2014
• Initial Date FDA Received: 06/16/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2014
• 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
• Patient Age: 64 YR