| Brand Name | G7 LONGEVITY HIGH WALL 32MM C |
| Common Device Name | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED |
| Manufacturer (Section D) |
| ZIMMER BIOMET, INC. |
| 1800 w. center st. |
| warsaw IN 46580 |
|
| Manufacturer (Section G) |
| ZIMMER BIOMET, INC. |
| 1800 w. center st. |
|
| warsaw IN 46580 |
|
| Manufacturer Contact |
|
jennifer
rapsavage
|
| 56 e. bell dr. |
| warsaw, IN 46582
|
|
5745260384
|
|
| MDR Report Key | 24568381 |
| Report Number | 0001822565-2026-00776 |
| Device Sequence Number | 9561277 |
| Product Code |
LPH
|
| UDI-Device Identifier | 00889024519251 |
| UDI-Public | (01)00889024519251(17)291216(10)67063942 |
| Combination Product (Y/N) | N |
| Initial Reporter Country | CH |
| PMA/510(K) Number | K190660 |
| Number of Events Summarized | 1 |
| Summary Report (Y/N) | N |
| Serviced by Third Party (Y/N) | Unknown |
| Reporter Type |
Manufacturer
|
| Report Source |
Foreign,Company Representative |
| Initial Reporter Occupation |
Non-Healthcare Professional
|
| Type of Report
| Initial,Followup |
| Report Date (Section B) |
04/23/2026 |
| 1 Device was Involved in the Event |
|
| 1 Patient was Involved in the Event |
|
| Is this an Adverse Event Report? |
No
|
| Is this a Product Problem Report? |
Yes
|
| Operator of Device |
Health Professional
|
| Device Catalogue Number | 20123203 |
| Device Lot Number | 67063942 |
| Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
| Was the Report Sent to FDA? |
No
|
| Type of Report(Section G) | Thirty-Day |
| Initial Date Received by Manufacturer | 02/25/2026 |
| Supplement Date Received by Manufacturer | 04/23/2026
|
| Initial Report FDA Received Date | 03/11/2026 |
| Supplement Report FDA Received Date | 04/24/2026
|
| Was Device Evaluated by Manufacturer? (Y/N) |
Yes
|
| Date Device Manufactured | 12/17/2024 |
| Is the Device Labeled for Single Use? (Y/N) |
Yes
|
Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N) |
No
|
| Usage of Device |
Initial
|
| Patient Sequence Number | 1 |
Concomitant Medical Products and Therapy/Usage Dates | SEE H11 NARRATIVE. |
| Patient Sex | Unknown |