FDA Adverse Event
Injury
Summary report: N
REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 8
MDR report key: 2715624
·
Received August 21, 2012
Report
- Report Number
- 2249697-2012-01315
- Event Type
- Injury
- Date Received
- August 21, 2012
- Date of Event
- August 3, 2012
- Report Date
- August 3, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- LZO
- PMA / PMN Number
- K071082
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT. CAT # NLS-340000B, LOT # 35286701, DESCRIPTION: LRG TAP PRI MOD NCK 0DEG 34MM. CAT # 6570-0-536, LOT # 37314605, DESCRIPTION: DELTA V-40 CERAMIC HEAD 36/+2.5. CAT # 623-00-36F, LOT # MKL43P, DESCRIPTION: TRIDENT 0X3 INSERT 36MM ID. CAT # 540-11-54F, LOT # 31773801, DESCRIPTION: TRIDENT PSL HA SOLID BACK 54 MM. 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 PT WAS REVISED DUE TO PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 8 | IMPLANT | LZO | STRYKER ORTHOPAEDICS MAHWAH | NA | MJTH92 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Other| R |