MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MCREYNOLDS IMPACTOR ADAPTER; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 6260-4-090

Device Problems Break (1069); Degraded (1153); Material Integrity Problem (2978)

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

Event Date 11/28/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that surgeon was explanting a stem with the mcreynolds adapter.After he extracted the stem he noticed the threads on the mcreynolds adapter was damaged and needed to be replaced.

Manufacturer Narrative

An event regarding thread damage involving a restoration modular adaptor was reported.The event was confirmed.-device evaluation and results: the device was returned in used condition.The device shows fourth and fifth thread damage observing from left to right.Review of device with material analyst engineer indicated damage observed on threads is consistent with cross threading.-medical records received and evaluation: not performed as patient factors did not contribute to the event.-device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies -complaint history review: there has been no other event for the lot referenced.On the basis of visual inspection, the investigation conclude that the device was returned in used condition.The device shows fourth and fifth thread damage observing from left to right.Also review of device with material analyst engineer indicated that the damage observed on threads is consistent with the cross threading.No further investigation for this event is possible at this time.If additional information becomes available, this investigation will be reopened.

Event Description

It was reported that surgeon was explanting a stem with the mcreynolds adapter.After he extracted the stem he noticed the threads on the mcreynolds adapter was damaged and needed to be replaced.

• Brand Name: MCREYNOLDS IMPACTOR ADAPTER
• 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 ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: rita intorrella ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6198753
• MDR Text Key: 63496326
• Report Number: 0002249697-2016-03993
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 02/28/2017

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: 6260-4-090
• Device Lot Number: TDER101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2016
• Initial Date FDA Received: 12/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2014
• 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