FDA Adverse Event
Injury
Summary report: N
REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 9
MDR report key: 2668501
·
Received July 19, 2012
Report
- Report Number
- 2249697-2012-00959
- Event Type
- Injury
- Date Received
- July 19, 2012
- Date of Event
- July 3, 2012
- Report Date
- July 2, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- MEH
- PMA / PMN Number
- K092561
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE FOLLOWING OTHER HIP DEVICES WERE ALSO LISTED IN THIS REPORT: LRG TAP PRI MOD NCK 0DEG 30MM, CAT# NLS-300000B, LOT# 37106301; TRIDENT PSL HA CLUSTER 48MM, CAT# 542-11-48D, LOT# MKH57D; TRIDENT 0 DEG X3 INSERT 32MM HEAD, CAT# 623-00-32D, LOT# MKD5XX; 32MMSTED LFIT V40 HEAD, CAT# 6260-9-132, LOT# 36317303; 6.5 CANCELLOUS BONE SCREW 30MM, CAT# 2030-6530-1, LOT# MKKEPK. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE PATIENTS MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S PAIN. WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "THE PATIENT COMPLAINED OF GROIN PAIN SO THE SURGEON REVISED THE LEFT HIP. SCREW ALSO REMOVED."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 9 | IMPLANT | MEH | STRYKER ORTHOPAEDICS MAHWAH | NA | MKJ244 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Required Intervention |