MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05 report with the FDA on 2014-08-18 for SECUR-FIT HA PSL CUP/CLUSTR SHELL 52MM 2051-2052 manufactured by Stryker Orthopaedics-mahwah.
[4846597]
It was reported that there was a removal of a series 2 insert due to wear of the insert. The surgeon also removed head.
Patient Sequence No: 1, Text Type: D, B5
[12259898]
The provided medical records and radiology images reviewed by a clinical consultant indicated that in addition to the reported liner wear, the shell appeared loose. The loosening was likely caused by osteolysis. The clinical consultant indicated that? The osteolysis should be considered secondary to the poly wear as it is universally known that polyethylene wear particles are osteolytic under the conditions prevailing in the arthroplasty joint.? It was also noted by the clinical consultant that no other procedure-related issues are present. Component position is adequate for both stem and cup. As such the root cause of this event is an adverse mix of patient-related and procedure-related factors and is not device-related. No device history review or complaint review was performed as the device was not properly identified. Not returned.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0002249697-2014-03131 |
| MDR Report Key | 4017516 |
| Report Source | 00,05 |
| Date Received | 2014-08-18 |
| Date of Report | 2013-09-18 |
| Date of Event | 2013-09-18 |
| Date Mfgr Received | 2014-08-04 |
| Date Added to Maude | 2014-08-18 |
| 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. SANDRA SPOKANE |
| 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 | 2014-08-18 |
| Catalog Number | 2051-2052 |
| 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 | 2014-08-18 |