FDA Adverse Event
Injury
Summary report: N
TRIDENT PSL WITH PUREFIX HA
MDR report key: 2149084
·
Received June 24, 2011
Report
- Report Number
- 2249697-2011-00954
- Event Type
- Injury
- Date Received
- June 24, 2011
- Date of Event
- March 21, 2009
- Report Date
- June 10, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- MEH
- PMA / PMN Number
- K983382
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE REPORTED DEVICES ARE STILL IMPLANTED IN THE PATIENT. A MEDICAL AUTHORIZATION WAS SENT TO THE PATIENT IN AN ATTEMPT TO RETRIEVE THE MEDICAL RECORDS FOR REVIEW. IF ADDITIONAL INFORMATION IS PROVIDED, THE RECORDS WILL BE REVIEWED BY A CLINICAL CONSULTANT AND THE RESULTS WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. ASSOCIATE DEVICES: SECUR-FIT MAX, CAT # 6052-1340S, LOT # MHA009 AND C-TAPER COCR LFIT HEAD 36MM/+10, CAT # 06-3610, LOT # UNKNOWN.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "(B)(6), 2009 FIRST DISLOCATION." THE PATIENT CAN NOT WALK VERY FAR WITHOUT PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIDENT PSL WITH PUREFIX HA | IMPLANT | MEH | STRYKER ORTHOPAEDICS MAHWAH | NA | 9W7MKD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Required Intervention |