FDA Adverse Event
Death
Summary report: N
UNKNOWN ZIMMER BURCH-SCHNEIDER
MDR report key: 6103704
·
Received November 15, 2016
Report
- Report Number
- 0001822565-2016-04238
- Event Type
- Death
- Date Received
- November 15, 2016
- Date of Event
- September 1, 2012
- Report Date
- November 15, 2016
- Manufacturer
- ZIMMER, INC.
- Product Code
- KWZ
- PMA / PMN Number
- PN/A
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
INFORMATION WAS RECEIVED VIA JOURNAL ARTICLE. ROGERS, ET AL. "THE RECONSTRUCTION OF PERIPROSTHETIC PELVIC DISCONTINUITY" JOURNAL TITLE 27:8 1499-1507.
Additional Manufacturer Narrative · 1
UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED AN MDR SHOULD NOT HAVE BEEN FILED UNDER THE CURRENT MFR NUMBER. THIS EVENT WILL BE REPORTED ON 0009613350-2017-00321.
Description of Event or Problem · 1
IT WAS REPORTED IN A JOURNAL ARTICLE THAT THERE WERE THREE CASES WERE REPORTED FOR DEATH. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 754765 | UNKNOWN ZIMMER BURCH-SCHNEIDER | HIP PROSTHESIS | KWZ | ZIMMER, INC. | N/A | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |