MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-28 for PROFEMUR? RENAISSANCE? STEM PLS0S410 manufactured by Microport Orthopedics Inc..
[182358804]
The alleged complaint is confirmed. The products were not returned, and no images were provided for evaluation. This incident was internally reported from a clinical study. Review of production records indicate that these products met all acceptance criteria at the time of manufacturing. There are no lot trends. This failure mode is listed in the device package insert and risk documentation. There were no trends identified. This issue will continue to be monitored through complaint tracking.
Patient Sequence No: 1, Text Type: N, H10
[182358805]
Allegedly, patient revised due to mom complications. Left. Sade#: (b)(4). Allegedly hip left revision was due to increased pain in hip.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010536692-2020-00069 |
| MDR Report Key | 9639468 |
| Date Received | 2020-01-28 |
| Date of Report | 2020-01-28 |
| Date of Event | 2019-04-02 |
| Date Facility Aware | 2019-10-04 |
| Date Added to Maude | 2020-01-28 |
| 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 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 | PROFEMUR? RENAISSANCE? STEM |
| Generic Name | HIP COMPONENT |
| Product Code | JDL |
| Date Received | 2020-01-28 |
| Model Number | PLS0S410 |
| Catalog Number | PLS0S410 |
| Lot Number | 095220565 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-01-28 |