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); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/06/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that the im plug has fractured.Update as per sales rep on (b)(6) 2016: after pulling the plug introducer up from the femoral canal, the plug still stays at the plug introducer and has broken.

Manufacturer Narrative

An event regarding a fractured device involving an exeter bone plug was reported.The event was confirmed based on the photograph provided.Method & results: device evaluation and results: the component was not returned for evaluation, however a photograph was provided which confirms the fractured bone plug.Medical records received and evaluation: not performed as no medical records were provided as the reported event was an intra-operative issue.Device history review: review of the dhr was satisfactory.Complaint history review: review of the complaints database confirmed that there were no other similar reported events.Conclusions: the exact cause of the event could not be determined with the available information.Return and evaluation of the reported device is required to complete the investigation for determining the root cause.No further investigation for this event is possible at this time as the device was not received by stryker orthopedics.If the device becomes available, this investigation will be reopened.

Event Description

The customer reported that the im plug has fractured.Update as per sales rep on 4/8/2016: after pulling the plug introducer up from the femoral canal, the plug still stays at the plug introducer and has broken.

Event Description

The customer reported that the im plug has fractured.Update as per sales rep on 4/8/2016: after pulling the plug introducer up from the femoral canal, the plug still stays at the plug introducer and has broken.

• 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: rita intorrella ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5626079
• MDR Text Key: 44354737
• Report Number: 0002249697-2016-01490
• 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,Followup
• Report Date: 07/13/2017

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 Expiration Date: 02/28/2021
• Device Catalogue Number: 09390114
• Device Lot Number: L8312
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/06/2016
• Initial Date FDA Received: 05/03/2016
• Supplement Dates Manufacturer Received: Not provided; 06/16/2017
• Supplement Dates FDA Received: 07/09/2016; 07/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2016
• 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