MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS PIP SZ. 30 PROXIMAL

Catalog Number PIP-200-30P-WW

Device Problems Break (1069); Material Integrity Problem (2978)

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

Event Date 09/18/2015

Event Type  Injury  

Event Description

It was reported the device broke and revision surgery was required.The surgeon performed a routine joint replacement with the device on (b)(6) 2015.All went well.The surgeon followed surgical technique.The patient presented after surgery with a complication.X-rays showed that the head of the proximal component had broken.The surgeon revised the implant on friday (b)(6) 2015.He removed the proximal component and implanted a new one, along with some impaction grafting.The surgeon is happy with the overall outcome, however not with broken implant.It was reported no patient injury is alleged.

Manufacturer Narrative

Complementary information received on (b)(6) 2015: the surgeon has confirmed that as yet there has been no report of infection-like symptoms from the patient.

Manufacturer Narrative

Integra has completed their internal investigation on nov/30/2015.The investigation included: methods: evaluation of actual device.Review of device history records.Review of complaints history.Results: evaluation of returned device; a visual examination of the implant was performed assisted by a stereomicroscope and oblique lighting.The 30p component fracture was found to be consistent with fractures known to result from impacting an unsupported head, where the stem of the component or trial cannot be fully inserted into the medullary canal due to an improperly prepared oblique osteotomy.Dhr review; one nonconformance was reported in (b)(4) related to coating thickness over specifications reported by the supplier.Integra (b)(4) reviewed the nonconformance and dispositioned it for use as is.No additional nonconformance was reported that could be related to the complaint.Complaints history; a review of complaints for pip implant fractures (both intra-op and post-op) during the last 5 years showed (b)(4) complaints.During this period of time there have been approximately (b)(4) units sold.The resulting rate of complaints is (b)(4) which does not represent an adverse trend.Conclusion: the cause of the failure has been identified as resulting from impacting the unsupported head when the stem of the implant has not been fully inserted into the medullary canal due to an improperly prepared oblique osteotomy.

Manufacturer Narrative

Product identification information provided.

• Brand Name: PIP SZ. 30 PROXIMAL
• Type of Device: 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: maria leonard ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5147086
• MDR Text Key: 28142031
• Report Number: 3004608878-2015-00269
• 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,Followup
• Report Date: 09/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PIP-200-30P-WW
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/02/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/28/2016
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention