MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07,company representative, report with the FDA on 2015-05-20 for MCP SZ. 30 PROXIMAL WW MCP-100-30P-WW manufactured by Ascension Orthopedics.
[5819566]
It was reported the implant device broke while being impacted. "the doctor was impacting the proximal implant using a impactor and a small mallet, it was all very normal, no excessive force was used. He gave it three taps and asked for an x-ray. From the x-ray we could see that the stem of the implant was broken. The case was extended about an hour because he had to get the broken tip out and then reinsert new implant. " it was reported no pt injury is alleged.
Patient Sequence No: 1, Text Type: D, B5
[13297554]
To date, the device involved in the reported incident has not been received for eval. An investigation has been initiated based upon the reported info.
Patient Sequence No: 1, Text Type: N, H10
[62571825]
Integra completed its internal investigation 07/15/2015. The investigation included: method dhr review, review of complaint management database for similar complaints, visual. Results: the manufacturing record for lot number 15-0043t mcp-100-30p-ww (mcp sz 30 proximal) was reviewed for nonconformities. The manufacturing record for each process step satisfied all applicable manufacturing specifications. No non-conformities were present and no issues were identified that would cause or contribute to the event. The manufacturing date is 01/15/2015. Complaint records with identical or similar hazardous situation/failure mode received during the lifetime of the product (typically 5 years) were reviewed to determine if the complaint represents an isolated incident or if it is part of an adverse trend. A total of (b)(4) complaints for fractured mcp implants were received during the last 5 years. Twelve of those failures resulted in revision surgery, with a severity level of "serious. " this was the highest severity level in all complaints received for fractured mcp implants during this timeframe. The device was returned for analysis on 06/04/2015. No conformance issues were recorded in the dhr. No manufacturing process problems were identified in the supplier's inspection record that would have caused or contributed to the event. The device was evaluated with the following findings: the complaint that the implant fractured is confirmed. There were no indications of irregularities or defects in the device. The fracture appearance is consistent with a rapid brittle, bending fracture. Stem fractures are known to occur upon impact used to seat the prosthesis during surgical implantation into an incompletely broached medullary canal. Conclusion: manufacturing processes are eliminated as a possible root cause for this complaint. Possible root causes as identified by the failure analysis: stem fractures are known to occur surgically upon seating impact as a result of incomplete broaching of the medullary canal. This is based on fracture studies. Possible root causes as identified in the design and application fmeas: surgical technique issues, especially improper implant handling, bone preparation, improper placement of implant, instrumentation use, pt selection, and implant size selection; implant design; instrumentation design; pt physiology pt's disease state and prior condition is unknown; off-label use of device. A definitive root cause cannot be determined at the time of report closure based on the information provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1651501-2015-00012 |
| MDR Report Key | 4791542 |
| Report Source | 06,07,COMPANY REPRESENTATIVE, |
| Date Received | 2015-05-20 |
| Date of Report | 2015-05-01 |
| Date Mfgr Received | 2015-05-01 |
| Device Manufacturer Date | 2015-01-15 |
| Date Added to Maude | 2015-06-19 |
| 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 | MARIA LEONARD |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362341 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MCP SZ. 30 PROXIMAL WW |
| Generic Name | MCP |
| Product Code | NEG |
| Date Received | 2015-05-20 |
| Returned To Mfg | 2015-06-04 |
| Catalog Number | MCP-100-30P-WW |
| Lot Number | 150043T |
| 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 78754 US 78754 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-05-20 |