MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 36MM -5MM V40 TRIAL HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Catalog Number 6264-8-036R

Device Problems Loose or Intermittent Connection (1371); Fitting Problem (2183); Insufficient Information (3190)

Patient Problems Injury (2348); No Known Impact Or Consequence To Patient (2692)

Event Date 09/23/2015

Event Type  malfunction  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was discarded.Additional information was requested and if it becomes available will be submitted in a supplemental report.

Event Description

It was reported that while trialing for a total hip the trial head was loose and was not locked on the trial neck and the surgeon could not dislocate hip.It was reported that after multiple attempts to dislocate the surgeon used an osteotome to break the trail head to get it removed.

Manufacturer Narrative

An event regarding seating/locking issues involving a partnership trial was reported.The event was not confirmed.Method & results: -device evaluation and results: could not be performed as no items associated with the event were returned or made available for identification or evaluation.-medical records received and evaluation: not performed because no medical records or x-rays were made available for evaluation.-device history review: a review of the device history records could not be performed as no lot information was provided.-complaint history review: a complaint history review could not be performed as no lot information was provided.Conclusions: the event could not be confirmed nor the root cause determined because the devices were not returned for evaluation and insufficient medical information was provided.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.No further investigation for this event is possible at this time as no devices and / or insufficient information was received by stryker orthopaedics.If devices and / or additional information become available, this investigation will be reopened.

Event Description

It was reported that while trialing for a total hip the trial head was loose and was not locked on the trial neck and the surgeon could not dislocate hip.It was reported that after multiple attempts to dislocate the surgeon used an osteotome to break the trail head to get it removed.

• Brand Name: 36MM -5MM V40 TRIAL HEAD
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
• 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: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5163718
• MDR Text Key: 29215573
• Report Number: 0002249697-2015-03426
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K122853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6264-8-036R
• Device Lot Number: AA153116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other