FDA Adverse Event
Injury
Summary report: N
TRIATHLON CR X3 TIBIAL INSERT
MDR report key: 2821523
·
Received October 24, 2012
Report
- Report Number
- 2249697-2012-02017
- Event Type
- Injury
- Date Received
- October 24, 2012
- Date of Event
- October 8, 2012
- Report Date
- October 4, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- HSH
- PMA / PMN Number
- K051146
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SD, US
- Reporter Occupation
- PHYSICIAN
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 DR (B)(6) SAID, THE PATIENT CAME IN REPORTING SOME PAIN AND INSTABILITY. HE THOUGHT A THICKER POLY WOULD HELP WITH THE INSTABILITY AND THE DEEPER DISH OF THE CS POLY SO HE REMOVED THE OLD CR 4X13X3 CR POLY AND REPLACED IT WITH A 4X19MM CS X3 POLY. AFTER REMOVING THE POLY, IT WAS DISCOVERED THAT THE POSTERIOR MEDIAL SIDE OF THE POLY HAD A PIECE THAT WAS CHIPPED OFF THE PIECE WAS RETRIEVED AND IS AT THE HOSPITAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIATHLON CR X3 TIBIAL INSERT | IMPLANT | HSH | STRYKER ORTHOPAEDICS MAHWAH | NA | 9VLMKD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Required Intervention |