G7 NEUTRAL E1 LINER 32MM D
Report
- Report Number
- 0001825034-2019-01057
- Event Type
- Injury
- Date Received
- March 11, 2019
- Date of Event
- January 15, 2019
- Report Date
- October 25, 2023
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- PBI
- UDI-DI
- 00880304526341
- PMA / PMN Number
- K121874
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: A4; B4; B5; B7; G3; H2; H6 IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. ADDITIONAL MEDICAL RECORDS PROVIDED; MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: HIP LUXATION, CLOSED REDUCTION. THE ADDITIONAL INFORMATION DOES NOT CHANGE THE OUTCOME OF THE PREVIOUS INVESTIGATION IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UDI - (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. SURGICAL NOTES WERE NOT PROVIDED. THE PATIENT PREVIOUSLY HAD A DISLOCATION AND IT WAS CLOSED REDUCED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
(B)(4). (B)(6). CONCOMITANT MEDICAL DEVICE: 32MM MOD HEAD COCR -3MM NECK, # ITEM 163668, LOT: RAJ6245267; G7 PPS LTD ACET SHELL 50D, # ITEM 010000662, LOT: 6258286; ECHO POR FMRL NC 11X135MM, # ITEM 192011, LOT: 842650. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-01056. REPORT SOURCE: (B)(6). CLINICAL STUDY: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
IT WAS REPORTED THAT THE PATIENT SUFFERED HIP DISLOCATION AND LUXATION APPROXIMATELY 40 DAYS POST SURGERY CLOSED REDUCTION WAS PERFORMED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 202576 | G7 NEUTRAL E1 LINER 32MM D | PROSTHESIS HIP | PBI | ZIMMER BIOMET, INC. | N/A | 3502958 | 00880304526341 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Female | Hospitalization| R |