FDA Adverse Event
Injury
Summary report: N
UNKNOWN ACCOLADE STEM
MDR report key: 18922059
·
Received March 18, 2024
Report
- Report Number
- 0002249697-2024-00438
- Event Type
- Injury
- Date Received
- March 18, 2024
- Date of Event
- February 20, 2024
- Report Date
- March 18, 2024
- Manufacturer
- STRYKER ORTHOPAEDICS-MAHWAH
- Product Code
- LPH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. H3 OTHER TEXT : DEVICE REMAINS IMPLANTED.
Description of Event or Problem · 0
SURGEON MENTIONED IN PASSING THAT A PREVIOUS PATIENT OF HIS, THAT HE¿D OPERATED ON IN 2017 HAD NECK IMPINGEMENT OF THE HIP STEM. HE HAD SEEN AN X-RAY BUT HAD NO OTHER DETAILS OTHER THAN IT WAS AN MDM/ ACCOLADE IN SITU.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 192690 | UNKNOWN ACCOLADE STEM | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED | LPH | STRYKER ORTHOPAEDICS-MAHWAH | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |