MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2015-10-14 for PIP SZ. 30 PROXIMAL PIP-200-30P-WW manufactured by Ascension Orthopedics.
[28142031]
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.
Patient Sequence No: 1, Text Type: D, B5
[31098429]
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.
Patient Sequence No: 1, Text Type: N, H10
[32888302]
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.
Patient Sequence No: 1, Text Type: N, H10
[45332376]
Product identification information provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004608878-2015-00269 |
| MDR Report Key | 5147086 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2015-10-14 |
| Date of Report | 2015-09-22 |
| Date of Event | 2015-09-18 |
| Date Mfgr Received | 2016-04-28 |
| Date Added to Maude | 2015-10-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | USER MARIA LEONARD |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | ASCENSION ORTHOPEDICS |
| Manufacturer Street | 8700 CAMERON ROAD #100 |
| Manufacturer City | AUSTIN TX 78754 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 78754 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PIP SZ. 30 PROXIMAL |
| Generic Name | PIP |
| Product Code | NEG |
| Date Received | 2015-10-14 |
| Returned To Mfg | 2015-11-02 |
| Catalog Number | PIP-200-30P-WW |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASCENSION ORTHOPEDICS |
| Manufacturer Address | 8700 CAMERON ROAD #100 8700 CAMERON ROAD #100 AUSTIN TX 78754 US 78754 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-10-14 |