MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-21 for PIP SZ. 30 PROXIMAL PIP-200-30P-WW manufactured by Ascension Orthopedics.
[34761802]
It was reported one of the implants broke when it was put in the patient and had to be taken out. The surgeon then proceeded with the same two implants and finished the case successfully. It was reported that although the device was in contact with the patient there was no patient injury.
Patient Sequence No: 1, Text Type: D, B5
[40740814]
Integra has completed their internal investigation on 14jan2016. The investigation activities included: methods: evaluation of actual device. 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 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 overall rate of complaints is (b)(4)). Trend analysis of the yearly complaints 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
| Report Number | 1651501-2015-00044 |
| MDR Report Key | 5313617 |
| Date Received | 2015-12-21 |
| Date of Report | 2015-12-03 |
| Date Mfgr Received | 2016-01-14 |
| Device Manufacturer Date | 2013-12-22 |
| Date Added to Maude | 2015-12-21 |
| 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. 30 PROXIMAL |
| Generic Name | PIP |
| Product Code | NEG |
| Date Received | 2015-12-21 |
| Returned To Mfg | 2016-01-08 |
| Catalog Number | PIP-200-30P-WW |
| Lot Number | 132871T |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2015-12-21 |