MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-07-14 for PIP SZ 40 PROXIMAL PIP-200-40P-WW manufactured by Ascension Orthopedics.
[22408083]
To date, the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based upon the reported information.
Patient Sequence No: 1, Text Type: N, H10
[22408084]
It was reported the device broke once both components were inserted and the surgeon was testing "rom" before closing. It was reported, "technique was followed according to the book. Both the trial and the definitive implants went in perfectly. Correct impactors were used. When (the surgeon) was testing rom, the proximal head fractured off. It was reported the patient was not injured.
Patient Sequence No: 1, Text Type: D, B5
[29835235]
Integra has completed their internal investigation on 10/12/2015. The investigation included: methods: evaluation of actual device. Review of device history records. Review of complaints history. Results: evaluation of returned device; examination under magnification of the returned implant shows the fracture area located near the base of the stem. This is consistent with other fractures that had been reported in the past. Dhr review; no nonconformances related to the complaint. Complaints history; the resulting rate of complaints during the last 5 years is (b)(4) which does not represent an adverse trend. Conclusion: a definitive root cause cannot be identified at this time, but the root cause of the fracture is most likely related to the technique used for bone preparation and/or impaction.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1651501-2015-00018 |
| MDR Report Key | 4918163 |
| Date Received | 2015-07-14 |
| Date of Report | 2015-06-18 |
| Date Mfgr Received | 2018-11-08 |
| Device Manufacturer Date | 2013-03-11 |
| Date Added to Maude | 2015-07-16 |
| 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 VIVIAN NELSON |
| 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 40 PROXIMAL |
| Product Code | OMX |
| Date Received | 2015-07-14 |
| Returned To Mfg | 2015-09-28 |
| Catalog Number | PIP-200-40P-WW |
| Lot Number | 13-0637 |
| 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 | AUSTIN TX 787543832 US 787543832 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-14 |