MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER 2.5 I M PLUG 16MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 09390116

Device Problems Break (1069); Fracture (1260); Inadequacy of Device Shape and/or Size (1583); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/14/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the cement plug was broken during inserting it into the canal.The surgeon tried to insert one size down plug(14mm), but it was small so it could not be locked.It was noted that the procedure was completed successfully with no impact to the patient.

Manufacturer Narrative

An event regarding a fractured device involving an exeter bone plug was reported.The event was confirmed.Method & results: -device evaluation and results: material analysis indicated that the exeter plug fractured in overload.No material or manufacturing defects were observed on the surfaces examined.-medical records received and evaluation: not performed as no medical records were provided.-device history review: dhr review was satisfactory.-complaint history review: complaint history review confirmed that there has been one other similar event for the reported lot.This other event was found to be not determined due to the insufficient information provided.Conclusions: material analysis determined that the exeter plug fractured in overload.No material or manufacturing defects were observed on the surfaces examined.A capa trend analysis was conducted for the reported failure mode and concluded that fracture of exeter bone plugs may result from factors such as errors made during use or design factors.No further investigation for this event is possible at this time.

Event Description

It was reported that the cement plug was broken during inserting it into the canal.The surgeon tried to insert one size down plug(14mm), but it was small so it could not be locked.It was noted that the procedure was completed successfully with no impact to the patient.

• Brand Name: EXETER 2.5 I M PLUG 16MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA
• Manufacturer Contact: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5216498
• MDR Text Key: 31210805
• Report Number: 0002249697-2015-03698
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: K980843
• 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: 10/14/2015

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 Expiration Date: 12/31/2018
• Device Catalogue Number: 09390116
• Device Lot Number: L6713
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/14/2015
• Initial Date FDA Received: 11/11/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other