MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05,health professional,oth report with the FDA on 2015-07-07 for FEMORAL STEM-STD NECK-SIZE 2 IMPLANT 186003-02 manufactured by Stryker Orthopaedics-mahwah.
[16851369]
It was reported that pst femoral stem loosened and was explanted along with the pst head and liner. A restoration hip was implanted.
Patient Sequence No: 1, Text Type: D, B5
[17171662]
Catalog number unknown at this time. Device description reported as unknown pst femoral stem. Additional information has been requested and if received will be submitted in a follow up report upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[31605470]
An event regarding loosening involving a mako stem was reported. The event was not confirmed. Method & results: device evaluation and results: the device was not returned for analysis. Medical records received and evaluation: insufficient information was received for review with a clinical consultant. Device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies complaint history review there has been no other event for the lot referenced. Conclusions: the exact cause of the event could not be determined because insufficient information was provided. Further information such as device details, device return, x-rays, operative reports, and patient medical records would be helpful in investigating this event further. If additional information and/or device become available, this investigation will be reopened.
Patient Sequence No: 1, Text Type: N, H10
[31605471]
It was reported that pst femoral stem loosened and was explanted along with the pst head and liner. A restoration hip was implanted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002249697-2015-02234 |
| MDR Report Key | 4896568 |
| Report Source | 00,05,HEALTH PROFESSIONAL,OTH |
| Date Received | 2015-07-07 |
| Date of Report | 2015-06-09 |
| Date of Event | 2015-06-09 |
| Date Mfgr Received | 2015-09-10 |
| Device Manufacturer Date | 2014-03-31 |
| Date Added to Maude | 2015-07-08 |
| 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. BEVERLY LIMA |
| Manufacturer Street | 325 CORPORATE DRIVE |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal | 07430 |
| Manufacturer Phone | 2018315000 |
| Manufacturer G1 | MAKO SURGICAL CORP. |
| Manufacturer Street | 2555 DAVIE ROAD |
| Manufacturer City | FORT LAUDERDALE FL 33317 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33317 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FEMORAL STEM-STD NECK-SIZE 2 IMPLANT |
| Generic Name | HIP JOINT METAL/CERAMIC/POLYMER SEMI-CONSTRAINED CEMENTED OR NONPOROUS UNCEMENTE |
| Product Code | OQI |
| Date Received | 2015-07-07 |
| Catalog Number | 186003-02 |
| Lot Number | 100096-01 |
| Device Expiration Date | 2019-03-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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. Required No Informationntervention | 2015-07-07 |