MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 32MM -4MM V40 TRIAL HEAD; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number 6264-8-032R

Device Problems Loose or Intermittent Connection (1371); Use of Device Problem (1670)

Patient Problems Inadequate Pain Relief (2388); No Code Available (3191)

Event Date 09/08/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during a hip operation (accolade ii - trident) the surgeon did a trial reduction with the accolade rasp and a v-40 trial head 32-4.The trident cup was already implanted with a 32 mm id insert.When the surgeon wanted to dislocate the hip again, the trial head was loose on the trial neck and it was impossible to dislocate.The anesthetist had to give more medication for relaxation of the patient and several attempts had to be made to dislocate.

Manufacturer Narrative

Corrected data: device was not returned.An event regarding a seating/locking issues involving a partnership trial head was reported.The event was not confirmed.Method & results: device evaluation and results: it was reported that the products are not available for analysis.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 exact cause of the event could not be determined because no device were available for analysis, previous investigations for similar reported events have concluded that the trial head were missing the o-ring and cause the trial to detach from the trunnion/.

Event Description

It was reported that during a hip operation (accolade ii trident) the surgeon did a trial reduction with the accolade rasp and a v-40 trial head 32-4.The trident cup was already implanted with a 32 mm id insert.When the surgeon wanted to dislocate the hip again, the trial head was loose on the trial neck and it was impossible to dislocate.The anesthetist had to give more medication for relaxation of the patient and several attempts had to be made to dislocate.

• Brand Name: 32MM -4MM V40 TRIAL HEAD
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER SUZHIOU; no. 18 wuxiang, epz zone a; 200 suhong road, sip; suzhou NJ 21502 1; CN 215021
• Manufacturer Contact: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5128022
• MDR Text Key: 27692140
• Report Number: 0002249697-2015-03246
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K122853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 09/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6264-8-032R
• Device Lot Number: SS136368
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2013
• 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