MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2015-12-29 for ORTHOSIZE DIGITAL TMP SOFTWARE N/A 9999997 manufactured by Biomet Orthopedics.
[34646610]
Current information is insufficient to permit a conclusion as to the cause of the event. There are warnings in the package insert that state that this type of event can occur: "a trained medical professional determines final implant type and size intraoperatively. " "orthosize software does not determine the final size and type of hardware to be implanted. "
Patient Sequence No: 1, Text Type: N, H10
[34646611]
It was reported that during an initial total hip arthroplasty procedure on an unknown date the orthosize v1. 2. 6 software did not correctly template the stem. The surgeon broached and attempted to implant the stem, but it did not fit. The stem was removed and the surgeon continuously broached until the appropriate size was reached.
Patient Sequence No: 1, Text Type: D, B5
[36865010]
This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.
Patient Sequence No: 1, Text Type: N, H10
[36865011]
It was reported that during an initial total hip arthroplasty procedure on (b)(6) 2015 the orthosize v1. 2. 6 software templated a size 8 stem. The surgeon broached to size 8 and attempted to implant the stem; however it did not fit. The stem was removed and the surgeon continuously broached until the appropriate size was reached. A size 14 stem was implanted.
Patient Sequence No: 1, Text Type: D, B5
[44041163]
This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch. Evaluation of software found no evidence of product non-conformance. Digital implant image comparison testing was conducted and all images were accurate. A conclusive root cause of the event could not be determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2015-05213 |
| MDR Report Key | 5333026 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2015-12-29 |
| Date of Report | 2016-04-28 |
| Date of Event | 2015-12-01 |
| Date Mfgr Received | 2016-04-28 |
| Date Added to Maude | 2015-12-29 |
| 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 | MS. MEGAN HAAS |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5743726700 |
| Manufacturer G1 | BIOMET ORTHOPEDICS |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ORTHOSIZE DIGITAL TMP SOFTWARE |
| Generic Name | SOFTWARE |
| Product Code | OSN |
| Date Received | 2015-12-29 |
| Model Number | N/A |
| Catalog Number | 9999997 |
| Lot Number | V1.2.6 |
| ID Number | N/A |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET ORTHOPEDICS |
| Manufacturer Address | 56 E. BELL DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-12-29 |