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 2015-08-13 for SECUR-FIT HA PSL CUP/CLUSTR SHELL 52MM 2051-2052 manufactured by Stryker Orthopaedics-mahwah.
[22854099]
A supplemental report will be submitted upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[22854100]
It was reported that the liner ring loosened and broke. Visible on xray.
Patient Sequence No: 1, Text Type: D, B5
[30548819]
An event regarding crack/fracture involving an omnifit liner was reported. Conclusion: the event was reported for a fractured liner, no allegation of failure was made against the shell. Based on the provided information, the product reported in this investigation did not contribute to the event. No further investigation is required at this time. If additional information and/or device becomes available this record will be reopened.
Patient Sequence No: 1, Text Type: N, H10
[30548820]
It was reported that the liner ring loosened and broke. Visible on xray.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002249697-2015-02624 |
| MDR Report Key | 5000274 |
| Report Source | HEALTH PROFESSIONAL,OTHER |
| Date Received | 2015-08-13 |
| Date of Report | 2015-07-14 |
| Date of Event | 2015-07-14 |
| Date Mfgr Received | 2015-09-10 |
| Date Added to Maude | 2015-08-13 |
| 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. WILLIAM HANNA |
| 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 | 2015-08-13 |
| Catalog Number | 2051-2052 |
| 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. Hospitalization; 2. Required No Informationntervention | 2015-08-13 |