MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS PIP SZ 40 PROXIMAL

Catalog Number PIP-200-40P-WW

Device Problems Break (1069); Detachment Of Device Component (1104); Fracture (1260); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

To date, the device involved in the reported incident has not been received for evaluation.An investigation has been initiated based upon the reported information.

Event Description

It was reported the device broke once both components were inserted and the surgeon was testing "rom" before closing.It was reported, "technique was followed according to the book.Both the trial and the definitive implants went in perfectly.Correct impactors were used.When (the surgeon) was testing rom, the proximal head fractured off.It was reported the patient was not injured.

Manufacturer Narrative

Integra has completed their internal investigation on 10/12/2015.The investigation included: methods: evaluation of actual device.Review of device history records.Review of complaints history.Results: evaluation of returned device; examination under magnification of the returned implant shows the fracture area located near the base of the stem.This is consistent with other fractures that had been reported in the past.Dhr review; no nonconformances related to the complaint.Complaints history; the resulting rate of complaints during the last 5 years is (b)(4) which does not represent an adverse trend.Conclusion: a definitive root cause cannot be identified at this time, but the root cause of the fracture is most likely related to the technique used for bone preparation and/or impaction.

Manufacturer Narrative

The head of the implant was retuned in (b)(4) 2018.Visual analysis of the head at the breaking point confirmed the previous conclusions drawn.Previous conclusion: a definitive root cause cannot be identified at this time, but the root cause of the fracture is most likely related to the technique used for bone preparation and/or impaction.

• Brand Name: PIP SZ 40 PROXIMAL
• Manufacturer (Section D): ASCENSION ORTHOPEDICS; austin TX 78754 3832
• Manufacturer (Section G): ASCENSION ORTHOPEDICS; 8700 cameron road #100; austin TX 78754
• Manufacturer Contact: vivian nelson ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 4918163
• MDR Text Key: 22408083
• Report Number: 1651501-2015-00018
• Device Sequence Number: 1
• Product Code: NEG
• Combination Product (y/n): N
• PMA/PMN Number: H010005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Followup,Followup
• Report Date: 06/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PIP-200-40P-WW
• Device Lot Number: 13-0637
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1