MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-08 for UNKNOWN SERIES I OR SERIES II CUP UNK_REC manufactured by Stryker Orthopaedics-mahwah.
[32982375]
A supplemental report will be submitted upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[32982376]
Right hip revision for pain, instability and osteolysis. Cup, screws, insert, stem and head were revised.
Patient Sequence No: 1, Text Type: D, B5
[37063122]
An event regarding instability involving unknown shell was reported. The event was not confirmed. Method and results: device evaluation and results: could not be performed as no items associated with the event were returned or made available for identification or evaluation. Medical records received and evaluation: no medical records or x-rays were made available for evaluation. Device history review: a review of the device history records could not be performed as no lot information was provided. Complaint history review: a complaint history review could not be performed as no lot information was provided. Conclusions: the event could not be confirmed nor the root cause determined because the devices were not returned for evaluation and insufficient medical information was provided. If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.
Patient Sequence No: 1, Text Type: N, H10
[37063123]
Right hip revision for pain, instability and osteolysis. Cup, screws, insert, stem and head were revised.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002249697-2015-04176 |
| MDR Report Key | 5275142 |
| Date Received | 2015-12-08 |
| Date of Report | 2015-11-13 |
| Date of Event | 2015-11-13 |
| Date Mfgr Received | 2016-01-06 |
| Date Added to Maude | 2015-12-08 |
| 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 | STRYKER ORTHOPAEDICS-MAHWAH |
| Manufacturer Street | 325 CORPORATE DRIVE |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07430 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN SERIES I OR SERIES II CUP |
| Generic Name | HIP IMPLANT |
| Product Code | KWB |
| Date Received | 2015-12-08 |
| Catalog Number | UNK_REC |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2015-12-08 |