MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS SILICONE PIP SZ. 1

Catalog Number SPIP-520-1-WW

Device Problems Fracture (1260); Material Integrity Problem (2978)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 03/23/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that on (b)(6) 2016, the surgeon implanted a silicone pip implant (size 1).Patient went back to activities of daily living and thinks she remembers an incident where she felt the implant give away.The surgeon scheduled her for a revision surgery to replace the fractured silicone implant with a new one.On (b)(6) 2017 surgeon removed the broken implant and replaced with a silicone pip (size 2) implant.Surgeon was not overly concerned and understands that a silicone implant, over time, can wear down and fractured.

Manufacturer Narrative

Integra has completed their internal investigation on may 3, 2017.Results: evaluation of returned device; the explanted device was returned, and visual failure analysis was performed.It was confirmed that the spip was returned in two pieces.No tool marks were visible on the stem.The failure timeline could not be determined (i.E.Sharp break or gradual); however, it appears that it may have been sudden based on the nature of the report.Dhr review; review of manufacturing records showed no evidence of a nonconformance that may have caused or contributed to the reported event.Complaints history; this complaint is the only complaint of post-operative spip breakage from january 2012 to present.During this period of time, there have been (b)(4) spip surgeries performed.This represents a (b)(4) overall failure rate.Conclusion: based on the information received to date, the root cause cannot be determined.The patient reported that she returned to activities of daily living and thinks she remembers an incident where she felt the implant give way; however, it is unknown if there was some sort of trauma or injury that occurred at the time she felt the implant give way.

• Brand Name: SILICONE PIP SZ. 1
• Type of Device: SILICONE PIP
• Manufacturer (Section D): ASCENSION ORTHOPEDICS; 8700 cameron road #100; 8700 cameron road #100; austin TX 78754
• Manufacturer (Section G): ASCENSION ORTHOPEDICS; 8700 cameron road #100; austin TX 78754
• Manufacturer Contact: sonia irizarry ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6499765
• MDR Text Key: 73020930
• Report Number: 1651501-2017-00013
• Device Sequence Number: 1
• Product Code: KYJ
• Combination Product (y/n): N
• PMA/PMN Number: K082231
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SPIP-520-1-WW
• Device Lot Number: 160124T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/03/2017
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention