CORIN METAFIX HIP STEM
Report
- Report Number
- 9614209-2022-00091
- Event Type
- Injury
- Date Received
- September 6, 2022
- Date of Event
- August 25, 2022
- Report Date
- November 23, 2022
- Manufacturer
- CORIN MEDICAL
- Product Code
- LZO
- PMA / PMN Number
- K082525
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- 501
Narratives
PER -(B)(4) INITIAL REPORT ADDITIONAL INFORMATION INCLUDING POST PRIMARY AND PRE REVISION X-RAYS, OPERATIVE NOTES, INFORMATION ON HOW WAS THE LOOSENING IDENTIFIED, WHETHER THE PATIENT EXPERIENCED ANY SLIPS / FALLS OR OTHER TRAUMA POST PRIMARY SURGERY, WHETHER THE PATIENT FOLLOWED CORRECT POST-OP PROTOCOL AND AN UPDATE ON THE PATIENT POST REVISION HAS BEEN REQUESTED IN ORDER TO PROGRESS WITH THE INVESTIGATION OF THIS EVENT, AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. THE APPROPRIATE DEVICE DETAILS HAVE BEEN PROVIDED AND THE RELEVANT DEVICE MANUFACTURING RECORDS WILL BE IDENTIFIED AND REVIEWED. PLEASE NOTE: THIS REPORT IS FILED WITH THE FDA DUE TO AN ADVERSE EVENT EXPERIENCED WITH A DEVICE THAT IS SIMILAR TO THOSE PLACED ON THE MARKET IN THE USA, HOWEVER, THIS EVENT OCCURRED OUTSIDE OF THE USA. THE SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, REPORTING ENTITY, ENTITY'S REPRESENTATIVE OR DISTRIBUTOR CAUSED OR CONTRIBUTED TO THIS EVENT.
PER -5035 FINAL REPORT. THE DEVICE DETAILS OF THE METAFIX STEM WERE INCORRECT IN THE INITIAL REPORT. THIS INFORMATION WAS CORRECTED IN THIS FINAL REPORT: SECTION D: UPDATED WITH MODEL, LOT CODE AND EXPIRATION DATE OF THE METAFIX STEM. SECTION G4: 510(K) UPDATED WITH K082525. SECTION H4: UPDATED ABOUT DEVICE MANUFACTURE DATE. ADDITIONAL INFORMATION INCLUDING POST PRIMARY AND PRE REVISION X-RAYS, OPERATIVE NOTES, INFORMATION ON HOW WAS THE LOOSENING IDENTIFIED, WHETHER THE PATIENT EXPERIENCED ANY SLIPS / FALLS OR OTHER TRAUMA POST PRIMARY SURGERY, WHETHER THE PATIENT FOLLOWED CORRECT POST-OP PROTOCOL AND AN UPDATE ON THE PATIENT POST REVISION HAS BEEN REQUESTED IN ORDER TO PROGRESS WITH THE INVESTIGATION OF THIS EVENT, HOWEVER THIS INFORMATION COULD NOT BE PROVIDED. THE APPROPRIATE DEVICE DETAILS HAVE BEEN PROVIDED AND THE RELEVANT DEVICE MANUFACTURING RECORDS HAVE BEEN IDENTIFIED AND REVIEWED. ALL PARTS ASSOCIATED WITH THESE RECORDS CONFORMED TO MATERIAL AND DIMENSIONAL SPECIFICATIONS AT THE TIME OF MANUFACTURE. BASED ON THE ABOVE, NO FURTHER INVESTIGATION CAN BE CONDUCTED AND THE ROOT CAUSE COULD NOT BE DETERMINED. THEREFORE, THIS CASE IS NOW CONSIDERED CLOSED. HOWEVER, SHOULD ADDITIONAL INFORMATION BE PROVIDED THEN THIS CASE MAY BE RE-OPENED FOR FURTHER INVESTIGATION. PLEASE NOTE: THIS REPORT IS FILED WITH THE FDA DUE TO AN ADVERSE EVENT EXPERIENCED WITH A DEVICE THAT IS SIMILAR TO THOSE PLACED ON THE MARKET IN THE USA, HOWEVER, THIS EVENT OCCURRED OUTSIDE OF THE USA. THE SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, REPORTING ENTITY, ENTITY'S REPRESENTATIVE OR DISTRIBUTOR CAUSED OR CONTRIBUTED TO THIS EVENT.
TRINITY REVISION OF ECIMA LINER, CERAMIC HEAD AND STEM AFTER APPROXIMATELY 1 YEAR 4 MONTHS DUE TO LOOSENING OF THE STEM.
TRINITY / METAFIX REVISION OF ECIMA LINER, CERAMIC HEAD AND STEM AFTER APPROXIMATELY 1 YEAR 4 MONTHS DUE TO LOOSENING OF THE STEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 135959 | CORIN METAFIX HIP STEM | METAFIX SIZE 6 LATERALIZED (135º) | LZO | CORIN MEDICAL | 579.1006 | 393297 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Male | Required Intervention| H | BIOLOX DELTA CERAMIC HEAD: 104.3605, 459538| BIOLOX DELTA CERAMIC HEAD: 104.3605, 459538| TRINITY CUP: 321.04.358, 459977| TRINITY CUP: 321.04.358, 459977| TRINITY ECIMA LINER: 322.04.636, 462875| TRINITY ECIMA LINER: 322.04.636, 462875 |