MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-02-07 for COCR TRANSCEND? FEMORAL HEAD 28MM SLT TAPER SHORT 26000017 manufactured by Microport Orthopedics Inc..
[178548212]
This event will be updated once the investigation is complete. Trends will be evaluated.
Patient Sequence No: 1, Text Type: N, H10
[178548213]
Allegedly, shell did not attach to the ball. Additional information on 01/31/2020: reporter stated that during surgery the head did not attach to the shell. They were using a 28 head and a 45 bipolar shell. According to the reporter, he noticed that the plastic rim inside the shell did not seem flush to the shell (there was a 3-4mm gap) and he thinks that it may be the reason why the head did not attach to the shell. In the end, they used a 32 head and a 46 shell. These functioned well.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010536692-2020-00105 |
| MDR Report Key | 9682793 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-02-07 |
| Date of Report | 2020-02-07 |
| Date Facility Aware | 2020-01-17 |
| Device Manufacturer Date | 2020-01-17 |
| Date Added to Maude | 2020-02-07 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 5677 AIRLINE ROAD |
| Manufacturer City | ARLINGTON TN 38002 |
| Manufacturer Country | US |
| Manufacturer Postal | 38002 |
| Manufacturer Phone | 9018674771 |
| Manufacturer G1 | MICROPORT ORTHOPEDICS INC. |
| Manufacturer Street | 5677 AIRLINE RD. |
| Manufacturer City | ARLINGTON TN 38002 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COCR TRANSCEND? FEMORAL HEAD 28MM SLT TAPER SHORT |
| Generic Name | HIP COMPONENT |
| Product Code | JDL |
| Date Received | 2020-02-07 |
| Returned To Mfg | 2020-01-17 |
| Model Number | 26000017 |
| Catalog Number | 26000017 |
| Lot Number | 1760412 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICROPORT ORTHOPEDICS INC. |
| Manufacturer Address | 5677 AIRLINE RD. ARLINGTON TN 38002 US 38002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-07 |