MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-21 for PIP SZ. 20 PROXIMAL PIP-200-20P-WW manufactured by Ascension Orthopedics.
[41144632]
It was reported the that during impaction the implant device exploded in the patient. No event circumstance or patient impact was provided. The distributor did not received complementary information from the hospital.
Patient Sequence No: 1, Text Type: D, B5
[42968610]
Integra has completed their internal investigation on april 7, 2016. The investigation activities included: methods: review of device history records. Review of complaint history. Results: the review of manufacturing records showed no evidence of nonconformance that could have caused or contributed to the reported defect. A review of complaints conducted for pip implant fractures (both intra-op and post-op) during the previous 5 years showed (b)(4) complaints, not including this one. During this period of time there have been approximately (b)(4) units sold. The resulting overall rate of complaints is (b)(4) ((b)(4)). A trend analysis of the yearly complaints conducted in (b)(6) 2016, shows it does not represent an adverse trend. Conclusion: in the past, similar issues that resulted in fractures have been attributed to improperly prepared oblique osteotomy, improper placement of the implant (e. G. , impacting unsupported head with too much force), or improper implant size selection. This possibility is currently under investigation by product development. A definitive root cause cannot be identified at this time, but the root cause of the fracture has been identified previously as most likely related to the technique used for bone preparation and/or impaction.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1651501-2016-00019 |
| MDR Report Key | 5515124 |
| Date Received | 2016-03-21 |
| Date of Report | 2016-03-01 |
| Date of Event | 2016-02-25 |
| Date Mfgr Received | 2016-04-07 |
| Device Manufacturer Date | 2014-11-20 |
| Date Added to Maude | 2016-03-21 |
| 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. 20 PROXIMAL |
| Generic Name | PIP |
| Product Code | NEG |
| Date Received | 2016-03-21 |
| Catalog Number | PIP-200-20P-WW |
| Lot Number | 142647T |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2016-03-21 |