MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-14 for PIP SZ. 20 PROXIMAL PIP-200-20P-WW manufactured by Ascension Orthopedics.
[26255351]
It was reported the surgeon was impacting the implant with minimal force and the implant broke. A second implant was taken out of the box and the same thing happened. Surgeon then had to go to a bigger size because we had no other 20ps available which added on another 1. 5 hours to the case. The surgeon is a new, 1st time user of the product. It was reported the patient was not injured.
Patient Sequence No: 1, Text Type: D, B5
[30330491]
Integra has completed their internal investigation on 23 oct 2015. The investigation activities included: methods: evaluation of actual device. Review of device history records. Review of complaint history. Results: device history record reviewed. The review did not identify a nonconformance related to the complaint. A review of complaints for pip implant fractures (both intra-op and post-op) during the last 5 years showed 61 complaints. During this period of time there have been (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 medullar canal due to an improperly prepared oblique osteotomy.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1651501-2015-00034 |
| MDR Report Key | 5074647 |
| Date Received | 2015-09-14 |
| Date of Report | 2015-08-19 |
| Date Mfgr Received | 2015-10-23 |
| Device Manufacturer Date | 2015-06-16 |
| Date Added to Maude | 2015-09-14 |
| 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 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 | OMX |
| Date Received | 2015-09-14 |
| Returned To Mfg | 2015-10-15 |
| Catalog Number | PIP-200-20P-WW |
| Lot Number | 151815T |
| 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 | 2015-09-14 |