FDA Adverse Event
Injury
Summary report: N
INSITU HIP SYSTEM
MDR report key: 8053457
·
Received November 8, 2018
Report
- Report Number
- 3002498892-2018-00016
- Event Type
- Injury
- Date Received
- November 8, 2018
- Date of Event
- October 4, 2018
- Report Date
- November 8, 2018
- Manufacturer
- THEKEN COMPANIES, LLC
- Product Code
- LPH
- UDI-DI
- 00816127022159
- PMA / PMN Number
- K161184
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO EXACT CAUSE OF THE FEMUR FRACTURE IS KNOWN. THERE HAS BEEN NO NON-CONFORMANCES RELATED TO THIS PRODUCT OR LOT. PRODUCT MALFUNCTION IS RULED OUT. SURGICAL TECHNIQUES, PATIENT CARE AFTER SURGERY, IMPLANT SIZING, ETC...THERE ARE MULTIPLE PROBABLE CAUSE FOR THIS EVENT. SINCE THIS IS A REPORTABLE ADVERSE EVENT, MDR IS FILED. NO ISSUE WITH PRODUCT OR PROCESSES.
Description of Event or Problem · 1
PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2018. REVISION CONDUCTED 10 DAYS AFTER PRIMARY. SURGEON TOOK OUT THE STEM AND TOOK OFF THE HEAD, BUT LEFT THE CUP AND LINER. FEMUR HAD FRACTURED MEDIALLY, AND STEM HAD SUBSIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 893179 | INSITU HIP SYSTEM | INSITU HIP REPLACEMENT SYSTEM | LPH | THEKEN COMPANIES, LLC | 10110008 | 1088 | 00816127022159 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |