FDA Adverse Event
Injury
Summary report: N
RESTORATION ADM X3 INS 28/48
MDR report key: 2233989
·
Received August 31, 2011
Report
- Report Number
- 9616680-2011-00576
- Event Type
- Injury
- Date Received
- August 31, 2011
- Date of Event
- August 16, 2011
- Report Date
- August 17, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- MEH
- PMA / PMN Number
- K093644
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "SALES REP RECEIVED A PHONE CALL FROM DOCTOR ON (B)(6) 2011 STATING THE PATIENT CAME INTO THE OFFICE. DOCTOR DID AN X-RAY AND DOCTOR BELIEVES THAT PATIENT DISLOCATED HIP. DOCTOR CLOSED REDUCING THE PATIENT THE SAME DAY (B)(6) 2011. AFTER, FURTHER EVALUATIONS WITH X-RAY, DOCTOR MADE THE DECISION TO MAKE AN EXPLORATORY CASE THE FOLLOWING DAY. ON (B)(6) 2011, UPON OPENING THE PATIENT, THE PRODUCT (B)(4) HAD DISASSOCIATED FROM (B)(4)."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORATION ADM X3 INS 28/48 | IMPLANT | MEH | STRYKER ORTHOPAEDICS CORK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Required Intervention |