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); Fitting Problem (2183); Material Integrity Problem (2978)

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

Event Date 06/13/2016

Event Type  malfunction  

Manufacturer Narrative

When completed, the investigation results will be submitted in a supplemental report.

Event Description

The surgeon reported that he did the trial measurement with plug trial nr 12 and it went totally into the femoral canal.He further reported that the trial would not seat in the right height of the canal.He did a trial with plug trial nr 14 it seated it the right place.He then placed the plug nr 14 in the plug introducer and placed it in the femoral canal.After removing the plug introducer from the canal he discovered that 3/4 of the plug still was placed at the introducer and 1/4 still was in the canal.He could pulse lavage this 1/4 out of the canal.

Manufacturer Narrative

An event regarding a fractured device involving an exeter bone plug was reported.The event was confirmed based on the returned product.Material analysis of the returned device concluded; the exeter plug fractured in overload, likely due to the force required to seat the device.There was no evidence of manufacturing or material defects on the device features evaluated.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: material analysis of the returned device indicated that the exeter plug fractured in overload, likely due to the force required to seat the device.No further investigation is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

The surgeon reported that he did the trial measurement with plug trial nr 12 and it went totally into the femoral canal.He further reported that the trial would not seat in the right height of the canal.He did a trial with plug trial nr 14 it seated it the right place.He then placed the plug nr 14 in the plug introducer and placed it in the femoral canal.After removing the plug introducer from the canal he discovered that 3/4 of the plug still was placed at the introducer and 1/4 still was in the canal.He could pulse lavage this 1/4 out of the canal.

• 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: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5784914
• MDR Text Key: 50021979
• Report Number: 0002249697-2016-02212
• 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: 06/13/2016

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: 03/31/2021
• Device Catalogue Number: 09390114
• Device Lot Number: L8315
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/13/2016
• Initial Date FDA Received: 07/12/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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