G7 OSSEOTI 4 HOLE SHELL 54MM F
Report
- Report Number
- 0001822565-2022-00593
- Event Type
- Injury
- Date Received
- February 25, 2022
- Date of Event
- January 2, 2022
- Report Date
- March 4, 2022
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- LPH
- UDI-DI
- 00880304544208
- PMA / PMN Number
- K140669
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). CONCOMITANT PRODUCTS: 193015 ¿ ECHO STEM ¿ 473220; 20103606 ¿ G7 LONGEVITY LINER ¿ 65056535; 650-0662 ¿ DELTA CERAMIC HEAD ¿ 473220. PROCEDURAL RELATED COMPLICATIONS ARE INFLUENCED BY THE TYPE OF SURGERY, PATIENTS PRE-EXISTING COMORBID STATE, AND PERIOPERATIVE MANAGEMENT. IF A DVT/ BLOOD CLOT BREAKS FREE, IT MAY TRAVEL THROUGH THE BLOODSTREAM AND BLOCK BLOOD FLOW TO THE LUNGS. THIS COMPLICATION IS CALLED A PULMONARY EMBOLISM. TOTAL JOINT PATIENTS ARE TYPICALLY PLACED ON MEDICATION POST-OPERATIVE FOR A PERIOD OF TIME TO HELP PREVENT THE DEVELOPMENT OF DVT/BLOOD CLOT FORMATION THAT CAN LEAD TO AN PE. AS THE COMPLAINT INDICATED THE PATIENT DEVELOPED A POST-OPERATIVE COMPLICATION, IT CAN BE IMPLIED MEDICAL INTERVENTION WAS COMPLETED TO TREAT THE PE. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2022-00587.
(B)(4). CONCOMITANT PRODUCTS: 193015 ¿ ECHO STEM ¿ 473220; 20103606 ¿ G7 LONGEVITY LINER ¿ 65056535; 650-0662 ¿ DELTA CERAMIC HEAD ¿ 473220. PROCEDURAL RELATED COMPLICATIONS ARE INFLUENCED BY THE TYPE OF SURGERY, PATIENTS PRE-EXISTING COMORBID STATE, AND PERIOPERATIVE MANAGEMENT. IF A DVT/ BLOOD CLOT BREAKS FREE, IT MAY TRAVEL THROUGH THE BLOODSTREAM AND BLOCK BLOOD FLOW TO THE LUNGS. THIS COMPLICATION IS CALLED A PULMONARY EMBOLISM. TOTAL JOINT PATIENTS ARE TYPICALLY PLACED ON MEDICATION POST-OPERATIVE FOR A PERIOD OF TIME TO HELP PREVENT THE DEVELOPMENT OF DVT/BLOOD CLOT FORMATION THAT CAN LEAD TO AN PE. AS THE COMPLAINT INDICATED THE PATIENT DEVELOPED A POST-OPERATIVE COMPLICATION, IT CAN BE IMPLIED MEDICAL INTERVENTION WAS COMPLETED TO TREAT THE PE. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2022-00587.
UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THIS PRODUCT SHOULD NOT HAVE BEEN REPORTED UNDER THIS MFR NUMBER. THIS REPORT SHOULD BE VOIDED AND A CORRECTED REPORT WILL BE FILED UNDER MFR NUMBER 1825034. UPDATED REPORT WILL BE UNDER 0001825034-2022-00481.
IT WAS REPORTED THAT A PATIENT DEVELOPED A PULMONARY EMBOLISM APPROXIMATELY 2 MONTHS POST LEFT TOTAL HIP ARTHROPLASTY. THE PATIENT WAS HOSPITALIZED OVERNIGHT, TREATED MEDICALLY AND RESOLVED THE NEXT DAY. COMPONENTS REMAIN IMPLANTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
IT WAS REPORTED THAT A PATIENT DEVELOPED A PULMONARY EMBOLISM APPROXIMATELY 2 MONTHS POST LEFT TOTAL HIP ARTHROPLASTY. THE PATIENT WAS HOSPITALIZED OVERNIGHT, TREATED MEDICALLY AND RESOLVED THE NEXT DAY. COMPONENTS REMAIN IMPLANTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THIS PRODUCT SHOULD NOT HAVE BEEN REPORTED UNDER THIS MFR NUMBER. THIS REPORT SHOULD BE VOIDED AND A CORRECTED REPORT WILL BE FILED UNDER MFR NUMBER 1825034.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1230541 | G7 OSSEOTI 4 HOLE SHELL 54MM F | PROSTHESIS, HIP | LPH | ZIMMER BIOMET, INC. | N/A | 65123551 | 00880304544208 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Hospitalization| O | SEE H10 |