FDA Adverse Event
Injury
Summary report: N
DUROM US ACETABULAR COMPONENT 64/58 X
MDR report key: 1192462
·
Received October 9, 2008
Report
- Report Number
- 9613350-2008-00153
- Event Type
- Injury
- Date Received
- October 9, 2008
- Date of Event
- July 1, 2008
- Report Date
- September 4, 2008
- Manufacturer
- ZIMMER GMBH
- Product Code
- KWA
- Removal / Correction Number
- 9613350-07/15/2008-001C
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFO WAS FORWARDED FROM THE OWNER ESTABLISHMENT, ZIMMER INC., WHICH MARKETS THE DEVICES IN THE U.S.
Description of Event or Problem · 1
IT WAS REPORTED THAT ONE MONTH POST-OP, PT WAS COMPLAINING OF HIP PAIN DURING PHYSICAL THERAPY. UPON FOLLOW-UP X-RAY DR NOTED CUP MOVEMENT. HE FEELS IN AN EFFORT NOT TO OVERREAM. CUP WAS REMOVED IN 2008 - NO BONE IN-GROWTH NOTED ON CUP. CUP CAME OUT EASILY. REPLACED BY TRILOGY & 40 HEAD/LINER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DUROM US ACETABULAR COMPONENT 64/58 X | DUROM ACETABULAR COMPONENT AND METASUL LDH LA | KWA | ZIMMER GMBH | 2357457 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Hospitalization| R |