RESTORATION (TM) ADM. CUP W/HA
Report
- Report Number
- 0002249697-2018-01541
- Event Type
- Injury
- Date Received
- May 23, 2018
- Date of Event
- January 19, 2018
- Report Date
- July 26, 2018
- Manufacturer
- STRYKER ORTHOPAEDICS-MAHWAH
- Product Code
- LPH
- PMA / PMN Number
- K121308
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
Narratives
ADDITIONAL INFO: EXECUTIVE SUMMARY, EXPIRATION DATE. AN EVENT REGARDING INFECTION INVOLVING AN ADM SHELL WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: PRODUCT EVALUATION AND RESULTS: VISUAL, DIMENSIONAL, FUNCTIONAL AND MATERIAL ANALYSIS COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. CLINICIAN REVIEW: A REVIEW OF THE AVAILABLE MEDICAL RECORDS WITH A CONSULTING CLINICIAN INDICATED THAT THE MEDICAL RECORD DOES NOT INCLUDE BACTERIOLOGY REPORTS, HISTOPATHOLOGY CONFIRMING METALOSIS OR EXAMINATION OF THE EXPLANTED COMPONENTS TO CONFIRM IMPINGEMENT. BASED UPON THE INFORMATION AVAILABLE FOR REVIEW, NO DETERMINATION CAN BE MADE REGARDING THE CAUSE OF THIS CLINICAL EVENT. PRODUCT HISTORY REVIEW: A DEVICE HISTORY REVIEW CONFIRMED ALL DEVICES ACCEPTED INTO FINISHED GOODS CONFORMED TO SPECIFICATION. COMPLAINT HISTORY REVIEW: NO OTHER EVENTS WERE REPORTED FOR THE LOT AND STERILE LOT INDICATED. CONCLUSION: IT WAS REPORTED THAT THE PATIENT HAD RIGHT HIP INFECTION. ALSO IT WAS NOTED THAT THE PATIENT HAD UNDERGONE FAILED HIP REPLACEMENT SECONDARY TO IMPINGEMENT AND SEVERE METALLOSIS. A REVIEW OF THE AVAILABLE MEDICAL RECORDS BY THE CONSULTING CLINICIAN NOTED THAT THE AVAILABLE INFORMATION WAS NOT SUFFICIENT TO DETERMINE THE CAUSE OF THE EVENT. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND / OR INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF DEVICES AND / OR ADDITIONAL INFORMATION BECOME AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED. THE INTERNAL INVESTIGATION OF STERILIZATION PROCESS AND RECORDS CONFIRMED THE PRODUCT MET SAL 10-6 PER CORRESPONDING ISO STANDARDS. A CAPA TREND ANALYSIS WAS CONDUCTED FOR THE REPORTED FAILURE MODE AND CONCLUDED INFECTION IS MOST LIKELY A RESULT FROM OTHER FACTORS NOT NECESSARILY RELATED TO THE DEVICE IN THE HEALTHCARE FACILITY SETTING.
AS REPORTED: "THIS PATIENT WAS PARTICIPATING IN STRYKER'S RESTORATION ADM X3 STUDY. AS PER THE ADVERSE EVENT FORM, THE "PATIENT REPORTS PAIN IN OUTER ASPECT OF HIP. PHYSICIAN NOTES TROCHANTERIC TENDERNESS AND NO NEUROVASCULAR DEFICIT." THE HIP WAS ASPIRATED AND THERE WAS FOUND TO BE A RIGHT HIP INFECTION. AS PER THE OPERATIVE NOTES, THE PATIENT WAS REVISED DUE TO A "FAILED HIP REPLACEMENT SECONDARY TO IMPINGEMENT AND SEVERE METALLOSIS." UPDATE 06/JUN/2018: PER REPORTER: "THE INFECTION WAS NEVER CLINICALLY CONFIRMED. THE INFECTION WAS SUSPECTED, BUT ENDED UP BEING THE METALLOSIS THAT IS MENTIONED."
IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.
AS REPORTED: "THIS PATIENT WAS PARTICIPATING IN STRYKER'S RESTORATION ADM X3 STUDY. AS PER THE ADVERSE EVENT FORM, THE "PATIENT REPORTS PAIN IN OUTER ASPECT OF HIP. PHYSICIAN NOTES TROCHANTERIC TENDERNESS AND NO NEUROVASCULAR DEFICIT." THE HIP WAS ASPIRATED AND THERE WAS FOUND TO BE A RIGHT HIP INFECTION. AS PER THE OPERATIVE NOTES, THE PATIENT WAS REVISED DUE TO A "FAILED HIP REPLACEMENT SECONDARY TO IMPINGEMENT AND SEVERE METALLOSIS.""
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 378822 | RESTORATION (TM) ADM. CUP W/HA | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED | LPH | STRYKER ORTHOPAEDICS-MAHWAH | G3633088 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Hospitalization| R |