MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 36MM +0(STD) V40 TRIAL HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 6264-8-136R

Device Problems Device Slipped (1584); Insufficient Information (3190)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 01/25/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Trial head will not stick to trunnion of implant.

Manufacturer Narrative

Product available to stryker.An event regarding an assembly issue involving a partnership trial head was reported.The event was not confirmed.Device history review: not performed as the device's lot id was not provided.Complaint history review: not performed as the device's lot id was not provided.It was reported that during surgery the trial head would not stick to the trunnion of implant.The event could not be confirmed nor the root cause be determined as the device was not returned for evaluation and sufficient information was not provided.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.Not returned to manufacturer.

Event Description

Trial head will not stick to trunnion of implant.

• Brand Name: 36MM +0(STD) V40 TRIAL HEAD
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• 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 21502 1; CN 215021
• Manufacturer Contact: rita intorrella ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6369929
• MDR Text Key: 69048340
• Report Number: 0002249697-2017-00718
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153345
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 05/05/2017

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 Catalogue Number: 6264-8-136R
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/31/2017
• Initial Date FDA Received: 03/01/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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