MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 26MM -3MM V40 TRIAL HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Catalog Number 6264-8-026

Device Problems Break (1069); Fracture (1260); Difficult To Position (1467)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Date 01/25/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was difficult to reposition for fracture, so they forced a reposition.The trial neck penetrated the trial head, and the upper part of the head was damaged due to a forced reposition.Replaced with another device and completed the procedure.

Manufacturer Narrative

Additional information: lot #; returned to manufacturer on; device evaluated by mfg; h4 device manufacture date.An event regarding crack/fracture involving a partnership trial head was reported.The event was confirmed.Review with the material analysis engineer stated that "the device fractured due to an overload condition, as determined by the hackles on the fracture surface." no medical records or x-rays were made available for evaluation.A device history review confirmed all devices accepted into finished goods conformed to specification.No other events were reported for the lot indicated.The investigation concluded that the reported fracture was caused by multiple overload conditions.Visual inspection indicated that the device was received with multiple small pieces fractured off.Review with the material analysis engineer stated that "device fractured due to an overload condition as indicated by the hackles observed on the fracture surface." no further investigation is possible at this time.If additional information become available, this investigation will be reopened and re-evaluated.

Event Description

It was difficult to reposition for fracture, so they forced a reposition.The trial neck penetrated the trial head, and the upper part of the head was damaged due to a forced reposition.Replaced with another device and completed the procedure.

• Brand Name: 26MM -3MM 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 ORTHOPAEDICS-MAHWAH; 325 corporate drive; 200 suhong road, sip; mahwah NJ 07430
• Manufacturer Contact: timothy rice ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6351689
• MDR Text Key: 68280354
• Report Number: 0002249697-2017-00635
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• 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: Initial,Followup
• Report Date: 01/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2015
• Device Catalogue Number: 6264-8-026
• Device Lot Number: AA155159
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2015
• 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