RESTORATION ADM X3 INS 28/48
Report
- Report Number
- 0002249697-2013-01600
- Event Type
- Injury
- Date Received
- May 9, 2013
- Date of Event
- April 10, 2013
- Report Date
- April 16, 2013
- Manufacturer
- STRYKER ORTHOPAEDICS-MAHWAH
- Product Code
- MEH
- PMA / PMN Number
- K093644
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- PHYSICIAN
Narratives
ADDITIONAL DEVICES LISTED IN THIS REPORT: CAT # 6021-2530, LOT # 38293904, DESCRIPTION: ACCOLADE (127 DEG) SIZE 2.5 ACCOLADE (127 DEG) SIZE 2.5. CAT # 6260-9-328, LOT # 37540002, DESCRIPTION: 28MM +8 LFIT V40 HEAD. CAT # 626-00-42E, LOT # 38493403, DESCRIPTION: MODULAR DUAL MOBILITY INSERT. CAT # 509-02-54E, LOT # MKRY9D, DESCRIPTION: TRITANIUM REVISION ACETABULAR. CAT # 2080-0035, LOT # MJH67T, DESCRIPTION: GAP PLATE SCREWS. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. DEVICE IMPLANTED.
THE PATIENT IS (B)(6) IN HEIGHT. AN EVENT REGARDING ADVERSE LOCAL TISSUE REACTION INVOLVING A RESTORATION ADM X3 INS 28/48 WAS REPORTED. THE EVENT WAS NOT CONFIRMED. MEDICAL RECORDS RECEIVED AND EVALUATION: INSUFFICIENT MEDICAL RECORDS WERE PROVIDED FOR REVIEW. DEVICE HISTORY REVIEW: A DEVICE HISTORY REVIEW CONFIRMED ALL DEVICES ACCEPTED INTO FINISHED GOODS CONFORMED TO SPECIFICATION. COMPLAINT HISTORY REVIEW: A COMPLAINT HISTORY REVIEW CONFIRMED NO SIMILAR EVENTS FOR THE REPORTED LOT. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE OF A LACK OF INFORMATION. FURTHER INFORMATION SUCH AS A CONFIRMATION OF THE REPORTED EVENT, X-RAYS, AND AN EVALUATION OF THE REPORTED DEVICES ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING THE ROOT CAUSE.
IT WAS REPORTED AS PER PHYSICIAN'S CORRESPONDENCE THAT THE PATIENT HAD SOME SYSTEMIC SYMPTOMS, WHICH RESOLVED AND ENDED UP WITH RESIDUAL HIP PAIN. PATIENT NOW HAS HIP PATHOLOGY AND SOME OSTEOLYSIS. AN ASPIRATE OF THE HIP SHOWED A HIGH AMOUNT OF PROTEINACEOUS DEBRIS. AS PER CLINIC NOTES, PATIENT'S C-REACTIVE PROTEIN WAS ELEVATED AT 1.6, SED-RATE WAS ELEVATED AT 29 AND MODERATELY ELEVATED COBALT AND CHROMIUM LEVELS. PATIENT IS ALSO HAVING CLEAR SYMPTOMS WITH HIP STRESS AND HIP EXAM AS WELL AS BONE LOSS. IT IS STATED THAT SOMETHING CLEARLY IS GOING ON, AND WHILE IT COULD BE AN INFECTION THAT HAS YET TO BE DETERMINED, PHYSICIAN IS CONCERNED IT IS ADVERSE LOCAL TISSUE REACTION DUE TO THE DISSIMILAR METALS. IT IS ANTICIPATED THAT THERE WILL BE A REVISION IN THE NOT TOO DISTANT FUTURE, EITHER FOR INFECTION THAT HAS YET TO BE DISCOVERED OR ADVERSE LOCAL TISSUE REACTION.
IT WAS REPORTED AS PER PHYSICIAN'S CORRESPONDENCE THAT THE PATIENT HAD SOME SYSTEMIC SYMPTOMS, WHICH RESOLVED AND ENDED UP WITH RESIDUAL HIP PAIN. PATIENT NOW HAS HIP PATHOLOGY AND SOME OSTEOLYSIS. AN ASPIRATE OF THE HIP SHOWED A HIGH AMOUNT OF PROTEINACEOUS DEBRIS. AS PER CLINIC NOTES, PATIENT'S C-REACTIVE PROTEIN WAS ELEVATED AT 1.6, SED-RATE WAS ELEVATED AT 29 AND MODERATELY ELEVATED COBALT AND CHROMIUM LEVELS. PATIENT IS ALSO HAVING CLEAR SYMPTOMS WITH HIP STRESS AND HIP EXAM AS WELL AS BONE LOSS. IT IS STATED THAT SOMETHING CLEARLY IS GOING ON, AND WHILE IT COULD BE AN INFECTION THAT HAS YET TO BE DETERMINED, PHYSICIAN IS CONCERNED IT IS ADVERSE LOCAL TISSUE REACTION DUE TO THE DISSIMILAR METALS. IT IS ANTICIPATED THAT THERE WILL BE A REVISION IN THE NOT TOO DISTANT FUTURE, EITHER FOR INFECTION THAT HAS YET TO BE DISCOVERED OR ADVERSE LOCAL TISSUE REACTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 203662 | RESTORATION ADM X3 INS 28/48 | IMPLANT | MEH | STRYKER ORTHOPAEDICS-MAHWAH | 38609001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Other |