EXETER V40 STEM 50MM NO 4
Report
- Report Number
- 0002249697-2014-03388
- Event Type
- Injury
- Date Received
- September 5, 2014
- Date of Event
- August 12, 2014
- Report Date
- August 12, 2014
- Manufacturer
- STRYKER ORTHOPAEDICS-MAHWAH
- Product Code
- JDI
- PMA / PMN Number
- K011623
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NZ
- Reporter Occupation
- PHYSICIAN
Narratives
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
AN EVENT REGARDING FRACTURE INVOLVING AN EXETER STEM WAS REPORTED. THE EVENT WAS CONFIRMED. DEVICE EVALUATION AND RESULTS: THE EXETER STEM FRACTURED IN FATIGUE WITH THE APPROXIMATE ORIGIN ON THE PROXIMAL SIDE OF THE DEVICE. LIKELY IMPINGEMENT WAS OBSERVED ON THE STEM TRUNNION. EVIDENCE OF MECHANICALLY-ASSISTED CORROSION WAS OBSERVED ON THE STEM UNRELATED TO THE FRACTURE. THE STEM MATERIAL WAS CONSISTENT WITH THE ASTM F1586 AND ISO 5832-9 STAINLESS STEEL ALLOY. NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED ON THE PART FEATURES EXAMINED. MEDICAL RECORDS RECEIVED AND EVALUATION: A REVIEW BY A CLINICAL CONSULTANT CONCLUDED THE FOLLOWING: ALL FACTS AND FINDINGS POINT TO CUP MALPOSITION THROUGH EXCESSIVE ANTEVERSION AS PRINCIPAL CAUSE OF ALL PROBLEMS. THERE WAS ALREADY AN ANTERIOR HIP DISLOCATION WITHIN TWO WEEKS OF ARTHROPLASTY REQUIRING REVISION WITH EXCHANGE OF THE DEPUY DURACON LINER FOR A SAME BRAND CONSTRAINED LINER. IT DID SOLVE THE INSTABILITY PROBLEM BUT IMPINGEMENT DID PERSIST AS EVIDENT FROM THE EXPLANT MATERIALS ANALYSIS AS WELL AS EVIDENT FROM THE X-RAY INFORMATION. FATIGUE DID BUILD UP OVER THE YEARS IN THE NECK SECTION OF THE EXETER STEM ULTIMATELY LEADING TO A FATIGUE FRACTURE AFTER 10-YEARS AS DOCUMENTED IN THE MAR. BECAUSE CUP MALPOSITION WAS THE ROOT PROBLEM, THE FAILURE MODE OF THIS PI CASE IS PROCEDURE-RELATED WITH POSSIBLY AN ADDITIONAL BUT SECONDARY CONTRIBUTION BY PATIENT-RELATED FACTORS OF OBESITY AND ECTOPIC BONE FORMATION IN THE JOINT. THIS PI CASE IS NOT DEVICE-RELATED AS ALSO SUPPORTED BY THE MAR FINDINGS. DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORD INDICATES DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: A REVIEW OF THE COMPLAINT HISTORY DATABASE SHOWS THAT THERE HAVE BEEN NO SIMILAR REPORTED EVENTS FOR THE SUBJECT LOT CODE. CONCLUSIONS: BASED ON THE CLINICAL REVIEW IT WAS DETERMINED THAT THE ROOT CAUSE OF THE EVENT WAS CUP MALPOSITION, WITH POSSIBLY AN ADDITIONAL BUT SECONDARY CONTRIBUTION BY PATIENT-RELATED FACTORS OF OBESITY AND ECTOPIC BONE FORMATION IN THE JOINT.
IT WAS REPORTED, "A REVISION OPERATION WAS PERFORMED ON A PATIENT WHO HAD A 50MM #4 STEM IMPLANTED APPROX 10 YEARS AGO. THE STEM HAD BROKEN NEAR THE STEM NECK JUNCTION. THE REVISION INCLUDED THE REMOVAL OF THE STEM THROUGH OSTEOTOMY OF THE FEMUR AND REMOVAL OF THE CONSTRAINED DURALOC LINER IN THE ACETABULUM. A LIMA REVISION FEMORAL SYSTEM AND SMITH AND NEPHEW BIPOLAR CEMENTED CUP WERE USED TO REPLACE THE REMOVED IMPLANTS."
IT WAS REPORTED, "A REVISION OPERATION WAS PERFORMED ON A PATIENT WHO HAD A 50MM #4 STEM IMPLANTED APPROX 10 YEARS AGO. THE STEM HAD BROKEN NEAR THE STEM NECK JUNCTION. THE REVISION INCLUDED THE REMOVAL OF THE STEM THROUGH OSTEOTOMY OF THE FEMUR AND REMOVAL OF THE CONSTRAINED DURALOC LINER IN THE ACETABULUM. A LIMA REVISION FEMORAL SYSTEM AND SMITH AND NEPHEW BIPOLAR CEMENTED CUP WERE USED TO REPLACE THE REMOVED IMPLANTS."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 545687 | EXETER V40 STEM 50MM NO 4 | IMPLANT | JDI | STRYKER ORTHOPAEDICS-MAHWAH | GB845238 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Other| R |