MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other report with the FDA on 2020-03-31 for UNKNOWN_ACCOLADE II STEM UNK_SHC manufactured by Stryker Orthopaedics-mahwah.
[186012036]
It was noted that the device is not available for evaluation. Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[186012037]
It was reported that the patient's right hip was revised due to a femoral periprosthetic fracture. Possible cause or contributor for bone fracture was not reported to the rep. An accolade ii stem and femoral head were being revised when the patient went into cardiac arrest (surgeon believes a cement restrictor pushed a clot into the patient's bloodstream). Patient was revived with chest compressions and a cemented omnifit stem was implanted with no cement as a spacer until the patient stabilized. The rep may be able to find primary usage information (catalog and lot), confirmed there are no allegations against the revised femoral head, and also confirmed that no further information will be released by the hospital or surgeon.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002249697-2020-00645 |
| MDR Report Key | 9904217 |
| Report Source | HEALTH PROFESSIONAL,OTHER |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-03 |
| Date Mfgr Received | 2020-03-03 |
| Date Added to Maude | 2020-03-31 |
| 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 | MR. MARISOL SANTIAGO |
| Manufacturer Street | 325 CORPORATE DRIVE |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal | 07430 |
| Manufacturer Phone | 2018315000 |
| Manufacturer G1 | STRYKER ORTHOPAEDICS-CORK |
| Manufacturer Street | IDA INDUSTRIAL ESTATE |
| Manufacturer City | CARRIGTWOHILL NA |
| Manufacturer Country | IE |
| Manufacturer Postal Code | NA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN_ACCOLADE II STEM |
| Generic Name | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED |
| Product Code | LPH |
| Date Received | 2020-03-31 |
| Catalog Number | UNK_SHC |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER ORTHOPAEDICS-MAHWAH |
| Manufacturer Address | 325 CORPORATE DRIVE MAHWAH NJ 07430 US 07430 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-03-31 |