FDA Adverse Event
Injury
Summary report: N
SECUR-FIT HA PSL CUP/CLUSTR SHELL 52MM
MDR report key: 5000274
·
Received August 13, 2015
Report
- Report Number
- 0002249697-2015-02624
- Event Type
- Injury
- Date Received
- August 13, 2015
- Date of Event
- July 14, 2015
- Report Date
- July 14, 2015
- Manufacturer
- STRYKER ORTHOPAEDICS-MAHWAH
- Product Code
- JDK
- PMA / PMN Number
- K965056
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Additional Manufacturer Narrative · 1
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.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LINER RING LOOSENED AND BROKE. VISIBLE ON XRAY.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LINER RING LOOSENED AND BROKE. VISIBLE ON XRAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 534059 | SECUR-FIT HA PSL CUP/CLUSTR SHELL 52MM | IMPLANT | JDK | STRYKER ORTHOPAEDICS-MAHWAH | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |