MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 36MM +0(STD) V40 TRIAL HEAD; INSTRUMENT

Catalog Number 6264-8-136R

Device Problems Degraded (1153); Material Integrity Problem (2978); Naturally Worn (2988)

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

Event Date 05/06/2015

Event Type  malfunction  

Event Description

It was reported that the inner retaining ring worn, does not stay on neck trial.

Manufacturer Narrative

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

Manufacturer Narrative

An event regarding a damaged o-ring involving a partnership trial head was reported.The event was confirmed.Method & results:-device evaluation and results: visual inspection confirmed the reported event.-medical records received and evaluation: not performed as medical records were not provided for evaluation.-device history review: review of device history records indicates the lot was manufactured and accepted into final stock free of discrepancies.-complaint history review: there have been no other events for the lot referenced.Conclusions: the investigation concluded that the reported damage to the teflon coating of the o-ring could result from repeated contact with the stem trunnion when seating and removing the trial head during surgical procedures.

Event Description

It was reported that the inner retaining ring worn, does not stay on neck trial.

• Brand Name: 36MM +0(STD) V40 TRIAL HEAD
• Type of Device: INSTRUMENT
• 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: william hanna ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4808631
• MDR Text Key: 5835235
• Report Number: 0002249697-2015-01760
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,health professional,oth
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6264-8-136R
• Device Lot Number: SS126699
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/23/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/20/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other