FDA Adverse Event
Injury
Summary report: N
DS10015328 SERF B MENTUM PFRKPE LINER 28 53
MDR report key: 20756001
·
Received November 22, 2024
Report
- Report Number
- 3008668801-2024-00001
- Event Type
- Injury
- Date Received
- November 22, 2024
- Date of Event
- October 11, 2024
- Report Date
- January 24, 2025
- Manufacturer
- S.E.R.F SOCIETE DETUDES RECHERCHE FABRICATION
- Product Code
- MEH
- UDI-DI
- 03662200015672
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.
Additional Manufacturer Narrative · 0
MANUFACTURER ENTITY D3 CORRECTED TO S.E.R.F SOCIETE DETUDES RECHERCHE FABRICATION.
Description of Event or Problem · 0
AS REPORTED VIA (B)(4): PATIENT WAS REVISED FOR INFECTED HIP. AFFECTED SIDE: RIGHT HIP.
Description of Event or Problem · 0
AS REPORTED VIA SERF (B)(4) AND DEPUY 1818910-2024-150024: PATIENT WAS REVISED FOR INFECTED HIP. AFFECTED SIDE: RIGHT HIP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2600934 | DS10015328 SERF B MENTUM PFRKPE LINER 28 53 | PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU | MEH | S.E.R.F SOCIETE DETUDES RECHERCHE FABRICATION | 1907666A | 03662200015672 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Hospitalization| R |