UNK HIP FEMORAL SLEEVE SROM
Report
- Report Number
- 1818910-2022-13439
- Event Type
- Injury
- Date Received
- July 19, 2022
- Date of Event
- November 30, 2020
- Report Date
- July 19, 2022
- Manufacturer
- DEPUY ORTHOPAEDICS INC US
- Product Code
- LPH
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THIS COMPLAINT WAS OPENED TO DOCUMENT COMPLAINTS DERIVED THROUGH A JOURNAL ARTICLE REVIEW. FOLLOW-UPS WERE DONE TO TRY AND OBTAIN ADDITIONAL INFORMATION FROM THE AUTHOR OF THE JOURNAL ARTICLE. NO FURTHER INFORMATION WAS RECEIVED. DEVICE HISTORY LOT : A MANUFACTURING RECORD EVALUATION (MRE), WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT CODE WAS NOT PROVIDED.
THIS COMPLAINT IS FROM A LITERATURE SOURCE. LITERATURE CITATION: KOBAYASHI K, KIDERA K, ITOSE M, MOTOKAWA T, CHIBA K, OSAKI M. HIGHER INCIDENCE OF ASEPTIC LOOSENING CAUSED BY A LOWER CANAL FILLING RATIO WITH A MODIFIED MODULAR STEM IN TOTAL HIP ARTHROPLASTY. J ORTHOP SURG RES. 2020 NOV 30;15(1):568. DOI: 10.1186/S13018-020-02101-X. PMID: 33256767; PMCID: PMC7706283. OBJECTIVE/METHODS/STUDY DATA: A TOTAL OF 144 PATIENTS (154 HIPS) WHO UNDERWENT TOTAL HIP ARTHROPLASTY USING THE MODULAR PROSTHESIS WERE RETROSPECTIVELY INVESTIGATED. FOR THE COHORT STUDY, 97 PATIENTS (104 HIPS) WERE INCLUDED. THE FEMORAL COMPONENT SURVIVAL RATE AND SLEEVE FIXATION WERE ASSESSED AT A MINIMUM FOLLOW-UP OF 5 YEARS. 97 PATIENTS (MALE, N = 20; FEMALE, N= 77; MEAN AGE AT SURGERY, 62 (36¿84) YEARS; FOLLOW-UP, 8 (5¿10) YEARS; HIPS, N = 104) WERE ASSESSED (FIG. 1). THE UNDERLYING DIAGNOSES WERE OSTEOARTHRITIS (N = 7; PRIMARY N = 89; SECONDARY), RHEUMATOID ARTHRITIS (N = 1), TRAUMA+B21(N = 2), RAPIDLY DESTRUCTIVE COXARTHROPATHY (N = 3), AND OSTEONECROSIS (N = 2). PATIENTS WERE DIVIDED INTO 2 GROUPS, INCLUDING STABLE AND UNSTABLE FIXATION GROUPS, BY SLEEVE FIXATION. CLINICAL AND RADIOGRAPHIC OUTCOMES WERE COMPARED. ALL PATIENTS RECEIVED DEPUY SROM STEM. THE ACETABULAR COMPONENT WAS EITHER A DEPUY PINNACLE-A CUP (QTY 96) OR A NON-DEPUY CEMENTED CUP (STD-CP BY JMM - QTY 8). ALL BEARING SURFACES WERE COBALT-CHROMIUM ON HIGHLY CROSS-LINKED POLYETHYLENE. SLEEVE FIXATION WAS CLASSIFIED AS STABLE (NO RADIOLUCENT LINES OR SLIGHT RADIOLUCENT LINES AROUND THE SLEEVE) OR UNSTABLE (EXTENSIVE RADIOLUCENT LINE AROUND THE SLEEVE WITH PROGRESSIVE SUBSIDENCE OR MIGRATION) ALTHOUGH THE ARTICLE DOES NOT SPECIFY WHICH MANUFACTURER DEVICE OF ACETABULAR SIDE ARE ASSOCIATED WITH THE ADVERSE EVENTS, THE MAJORITY OF PATIENTS WERE IMPLANTED WITH DEPUY PRODUCTS. FOR THIS REASON, QUANTITIES CANNOT BE ACCURATELY DETERMINED UNTIL ADDITIONAL INFORMATION IS RECEIVED FROM PERFORMING FOLLOW UP ACTIVITY. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: QTY 5 LOOSE STEMS TREATED WITH REVISION. QTY 1 DISLOCATION TREATED WITH REVISION. QTY 8 INTRAOPERATIVE FRACTURES (IMPACTION INSTRUMENTS ARE NOT IDENTIFIED WITHIN THE ARTICLE). QTY 1 POST-OPERATIVE PERIPROSTHETIC FRACTURE (NO TREATMENT SPECIFIED). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS SPECIFICALLY FOR THE SROM SLEEVE: QTY 16 HIPS CATEGORIZED WITH UNSTABLE FIXATION (EXTENSIVE RADIOLUCENT LINES WITH PROGRESSIVE SUBSIDENCE OR MIGRATION) RADIOGRAPHIC FINDINGS ONLY NO TREATMENT PROVIDED - EXAMPLE WITHOUT PATIENT IDENTIFIERS ILLUSTRATED IN FIGURE 2 (D).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 261569 | UNK HIP FEMORAL SLEEVE SROM | FEMORAL SLEEVE | LPH | DEPUY ORTHOPAEDICS INC US |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |