MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 VITALLIUM HEAD 28+6MM; IMPLANT

Catalog Number 6260-5-628

Device Problem Connection Problem (2900)

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

Event Date 09/01/2014

Event Type  malfunction  

Event Description

It was reported that, during the tha (mdm system), a surgeon tried to connect the reported v40 head on a stem trunnion.However, he could not connect it due to a plastic part in the taper of the head.Therefore, he used 36mm head and x3 liner instead.

Manufacturer Narrative

An event related to a packaging issue where plastic material was found within the metal head taper involving a v40 vitallium head 28+6mm was reported.The event was confirmed.Device evaluation and results: plastic material was identified in the female taper of the femoral head.The head itself was unremarkable medical records received and evaluation: not performed as no adverse consequences to the patient were reported and the device was not implanted.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 lot referenced.Conclusions: the plastic material found on the returned head has its origins related to the packaging associated with the femoral head packaging, a non conformance was raised to further investigate the issue.

• Brand Name: V40 VITALLIUM HEAD 28+6MM
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4119550
• MDR Text Key: 16181759
• Report Number: 0002249697-2014-03610
• 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
• Report Date: 09/01/2014

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: 02/28/2015
• Device Catalogue Number: 6260-5-628
• Device Lot Number: 32491001
• Other Device ID Number: STERILE LOT 1002FM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/01/2014
• Initial Date FDA Received: 09/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2010
• 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: 79 YR
• Patient Weight: 80