MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05 report with the FDA on 2013-09-17 for SECUR-FIT HA PSL CUP/CLUSTR SHELL 52MM 2051-2052 manufactured by Stryker Orthopaedics-mahwah.
[3867157]
Revised cup and femoral stem due to loosening. Everything was removed.
Patient Sequence No: 1, Text Type: D, B5
[11199977]
An evaluation of the device cannot be performed as the device was not returned to the manufacturer due to hospital policy. Additional information (including x-rays and medical records) has been requested. Should additional information become available, the evaluation summary will be submitted in a supplemental report. Device not returned to the manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[22636511]
The patient is (b)(6) in height. The reported lot code was determined to be not valid. An event regarding loosening involving a securfit shell was reported. The event was not confirmed. The investigation concluded that the exact cause of the event could not be determined because further information such pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes and the return of the devices are needed to complete the investigation. It also concluded that there is no indication the event is related to a manufacturing issue.
Patient Sequence No: 1, Text Type: N, H10
[22636512]
Revised cup and femoral stem due to loosening. Everything was removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002249697-2013-03061 |
| MDR Report Key | 3353426 |
| Report Source | 00,05 |
| Date Received | 2013-09-17 |
| Date of Report | 2013-08-26 |
| Date of Event | 2013-08-26 |
| Date Mfgr Received | 2014-03-07 |
| Device Manufacturer Date | 1995-05-03 |
| Date Added to Maude | 2013-09-17 |
| 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 | 0 |
| Event Location | 0 |
| 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 | SECUR-FIT HA PSL CUP/CLUSTR SHELL 52MM |
| Generic Name | IMPLANT |
| Product Code | JDK |
| Date Received | 2013-09-17 |
| Catalog Number | 2051-2052 |
| Lot Number | UNK |
| ID Number | STERILE LOT# 9505C |
| Device Expiration Date | 2000-05-02 |
| 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 | 2013-09-17 |