FDA Adverse Event
Injury
Summary report: N
TRILOGY STANDARD LINER
MDR report key: 3122190
·
Received May 17, 2013
Report
- Report Number
- 1822565-2013-00822
- Event Type
- Injury
- Date Received
- May 17, 2013
- Date of Event
- April 11, 2013
- Report Date
- April 18, 2013
- Manufacturer
- ZIMMER, INC.
- Product Code
- LPH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
EVALUATION SUMMARY: THE ZIMMER STERILIZATION VENDOR PROCESSES ALL IMPLANTS TO MEET FDA REGULATIONS AND ISO STANDARDS AT A STERILITY ASSURANCE LEVEL (SAL) OF 1.0 X 10-6 OR BETTER. THEREFORE, IT IS HIGHLY UNLIKELY THAT THE SPECIFIED DEVICE CAUSED OR CONTRIBUTED TO ANY PT INFECTION. THE RETURNED ASSEMBLY WAS LOCKED TOGETHER AS THE LOCKING RING WAS DAMAGED SUCH THAT THE LINER AND SHELL ARE LOCKED TOGETHER. THE LINER HAD SOME DISCOLORATION FROM BEING IN VIVO. THE LINER HAS DAMAGE TO THE RIM FROM ATTEMPTS TO BE REMOVED FROM THE LINER. DEVICE HISTORY RECORDS INDICATE ALL COMPONENTS WERE MANUFACTURED AND INSPECTED TO SPECIFICATION.
Description of Event or Problem · 1
IT IS REPORTED THAT THE PT WAS REVISED DUE TO INFECTION. THE SURGEON MENTIONED THE LINER LOOKED A BIT DULL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 218805 | TRILOGY STANDARD LINER | LPH | ZIMMER, INC. | 60018108 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Required Intervention | MANUFACTURED BY ZIMMER (B)(4)| TRILOGY SHELL WITH CLUSTER HOLES:| CATALOG #00620005222, LOT #60023049 |