FDA Adverse Event
Injury
Summary report: N
G7 DUAL MOBILITY LINER 44MM F
MDR report key: 25315821
·
Received May 28, 2026
Report
- Report Number
- 0001825034-2026-01479
- Event Type
- Injury
- Date Received
- May 28, 2026
- Date of Event
- May 4, 2026
- Report Date
- May 28, 2026
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- LPH
- PMA / PMN Number
- K150522
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
(B)(4). D10: 28MM I.D. 44MM O.D. SIZE F BEARING ITEM: 110031012 LOT: 65254637 DELTA CER FEM HD 28/-3MM T1 ITEM: 650-1159 LOT: 3090670 TPRLC 133 FP TYPE1 PPS SO 6.0 ITEM: 51-100060 LOT: 51-100060 G7 OSSEOTI 4 HOLE SHELL 54MM F ITEM: 110010245 LOT: 65300582 BONE SCREW SELF-TAPPING 6.5 MM DIA. 20 MM LENGTH ITEM: 00625006520 LOT: 65292772 THE PRODUCT WAS REQUESTED BUT WAS NOT RETURNED BY THE HOSPITAL AND WILL THEREFORE NOT BE SENT TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL MDR WILL BE SUBMITTED.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT UNDERWENT A G7 DUAL MOBILITY HIP REVISION DUE TO DISLOCATION. IT WAS CONFIRMED THAT NO FURTHER INFORMATION COULD BE PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 584356 | G7 DUAL MOBILITY LINER 44MM F | PROSTHESIS, HIP | LPH | ZIMMER BIOMET, INC. | 739070 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |