MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER 2.5 I M PLUG 14MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 09390114

Device Problems Break (1069); Fracture (1260); Difficult to Insert (1316); Material Integrity Problem (2978)

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

Event Date 12/01/2015

Event Type  malfunction  

Manufacturer Narrative

Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.Device was implanted.

Event Description

It was reported that the exeter 2.5mm intramedullary plug broke during insertion into the patient's femur during hip replacement.The surgeon was offered a replacement plug but he declined stating that it was too late.The procedure was completed.

Manufacturer Narrative

An event regarding a fractured device involving an exeter bone plug was reported.The event was confirmed.Method and results: device evaluation and results: the device was not returned however one photograph was provided.The photograph idenitifies the bone plug still attached to the introducer.The bone plug is fractured and the piece that broke off is not present in the photograph.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 have been no other similar events for the reported lot.Conclusions: visual inspection of the photograph provided confirms the reported event.The exact cause of the event could not be determined with the available information.Return of the reported device for evaluation is required to complete the investigation for determining the root cause.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 exeter 2.5mm intramedullary plug broke during insertion into the patient's femur during hip replacement.The surgeon was offered a replacement plug but he declined stating that it was too late.The procedure was completed.

• Brand Name: EXETER 2.5 I M PLUG 14MM
• 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: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5313988
• MDR Text Key: 34740115
• Report Number: 0002249697-2015-04379
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 12/02/2015

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: 09/30/2020
• Device Catalogue Number: 09390114
• Device Lot Number: L8297
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2015
• Initial Date FDA Received: 12/21/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2015
• 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