FDA Adverse Event
Injury
Summary report: N
REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 8
MDR report key: 2705813
·
Received August 13, 2012
Report
- Report Number
- 2249697-2012-01155
- Event Type
- Injury
- Date Received
- August 13, 2012
- Date of Event
- November 11, 2010
- Report Date
- July 20, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- JDI
- PMA / PMN Number
- K071082
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: CAT # NLS-380000B, LOT # 26582101, DESCRIPTION: LRG TAP PRI MOD NCK 0 DEG 38MM; CAT # 502-11-52E, LOT # 31346601, DESCRIPTION: TRIDENT HEMISPHERICAL CLUSTER HOLE SHELL; CAT # 623-00-36E, LOT # MJHEWE, DESCRIPTION: TRIDENT 0 DEG X3 INSERT 36MM ID; CAT # 6260-9-036, LOT # MJA560, DESCRIPTION: V40 COCR LFIT HEAD 36MM/-5; CAT # 2030-6520, LOT # MHTJRY, DESCRIPTION: CANCELLOUS BONE SCREW 6.5MM. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PT'S EXPERIENCE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SURGEON REMOVED IMPLANTS DUE TO STREP INFECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 8 | IMPLANT | JDI | STRYKER ORTHOPAEDICS MAHWAH | NA | MHR9ML |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Other| R |