MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS SILICONE PIP SZ. 2

Catalog Number SPIP-520-2-WW

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

The product was not returned for evaluation.Review of manufacturing records showed no evidence of a nonconformance that may have caused or contributed to the reported event.Based on the information received to date, the root cause is undetermined.The event may be due to trauma or an improperly seated implant leading to additional stress on the hinge may have caused or contributed to the event.

Event Description

It was reported that a spip-520-2-ww silicone pip implant showed signs of tear and breakage.On (b)(6) 2016, an athrodesis of the pipj was performed with a spip-520-2-ww silicone pip implant.However, 2 years post implantation, the implant showed signs of tear and breakage with signs of lateral shift.No specific trauma or contributing events prior to the discovery of the issue.Subsequently, the implanted product was explanted on (b)(6) 2018 and was replaced with another of the same size.No further patient complications were reported and the patient was doing well after the procedure.

• Brand Name: SILICONE PIP SZ. 2
• 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: vivian nelson ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 7566856
• MDR Text Key: 109996538
• Report Number: 1651501-2018-00028
• 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,foreig
• Reporter Occupation: Dental Hygienist
• Type of Report: Initial
• Report Date: 05/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SPIP-520-2-WW
• Device Lot Number: 161334T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 58 YR