MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 32MM +8MM V40 TRIAL HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 6264-8-332

Device Problems Sticking (1597); Detachment of Device or Device Component (2907); Insufficient Information (3190)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 10/20/2015

Event Type  malfunction  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Not returned to manufacturer.

Event Description

When the surgeon does ashy knees test, the head trials are coming off trunnion and sticking inside the cup.

Manufacturer Narrative

The reported lot number was found to be invalid.An event regarding assembly issue involving a 32mm +8mm v40 trial head 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.-and/or x-rays by a clinical consultant indicated: there is no specific information on the technique the surgeon uses for his trail testing.There is no evidence for any device-related problem and as such this event is not device-related." 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: medical review indicated "there is no specific information on the technique the surgeon uses for his trail testing." there is no evidence for any device-related problem.The exact cause of the event could not be determined due to insufficient provision of information.Further information such as: return of reported device is needed to complete the investigation to determine root cause.No further investigation is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

When the surgeon does ashy knees test, the head trials are coming off trunnion and sticking inside the cup.

• Brand Name: 32MM +8MM 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 NJ 21502 1; CN 215021
• Manufacturer Contact: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5226670
• MDR Text Key: 31573518
• Report Number: 0002249697-2015-03756
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151264
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6264-8-332
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2015
• 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
• Patient Age: 73 YR
• Patient Weight: 84