STAND. ACETAB. CEM. CUP Ø52MM
Report
- Report Number
- 3008021110-2023-00068
- Event Type
- Injury
- Date Received
- June 6, 2023
- Date of Event
- November 14, 2022
- Report Date
- February 27, 2024
- Manufacturer
- LIMACORPORATE S.P.A.
- Product Code
- LPH
- PMA / PMN Number
- K112158
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
NO PRE-EXISTING ANOMALY DETECTED BY THE CHECK OK THE DEVICE HISTORY RECORDS OF THE LOT NUMBER INVOLVED (1002850). THIS IS THE FIRST AND ONLY COMPLAINT REGISTERED ON THIS LOT NUMBER. WE WILL SUBMIT A FINAL REPORT AFTER THE INVESTIGATION.
CHECKING THE DEVICE HISTORY RECORDS AND RAW MATERIAL CERTIFICATE OF THE INVOLVED LOT. 1002850 - STER. 1000146, NO PRE-EXISTING ANOMALY WAS FOUND ON A TOTAL OF (B)(4) ITEMS MANUFACTURED WITH THE SAME LOT NUMBER. ACCORDING TO OUR RECORDS, AT LEAST 27 OUT OF 37 WITH LOT. 1002850 - STER. 1000146 HAVE BEEN IMPLANTED AND THIS IS THE ONLY COMPLAINT RECEIVED ON THIS LOT NR. COMPLAINT SOURCE PROVIDED TO LIMACORPORATE TEN X-RAYS WITH THE FOLLOWING DATE REFERENCE: (B)(6) 2010 - PRE-OPERATIVE PRIMARY SURGERY. (B)(6) 2010 - POST-OPERATIVE PRIMARY SURGERY. (B)(6) 2011 - 6 MONTHS POST-OPERATIVE PRIMARY SURGERY. (B)(6) 2013 - 2 YEARS POST-OPERATIVE PRIMARY SURGERY. (B)(6) 2017 - 7 YEARS POST-OPERATIVE PRIMARY SURGERY. (B)(6) 2019 - 9 YEARS POST-OPERATIVE PRIMARY SURGERY. (B)(6) 2020 - 10 YEARS POST-OPERATIVE PRIMARY SURGERY. (B)(6) 2021 - 11 YEARS POST-OPERATIVE PRIMARY SURGERY. (B)(6) 2022 - 12 YEARS POST-OPERATIVE PRIMARY SURGERY. (B)(6) 2023 - 7 MONTHS POST-OPERATIVE REVISION SURGERY. THE X-RAYS RECEIVED HAVE BEEN EVALUATED BY A MEDICAL CONSULTANT. FOLLOWING, THE MEDICAL CONSULTANT COMMENTS: "THE CEMENTED CUP WAS IMPLANTED IN 2010. SEEMS TO BE CORRECTLY FIXED. IN 2017 LOOSENING OF THE CUP WITH MODERATE ABRASION OF THE PE IS ALREADY EVIDENT, REVISION WOULD HAVE BEEN INDICATED. UNTIL 2022 PROGRESSIVE LOOSENING AND CONSUMPTION OF BONE STOCK CAN BE IDENTIFIED. REVISION IN 2023 WAS DONE USING AN UNCEMENTED JUMBO-CUP. THE FIXATION APPEARS TO BE DONE CORRECTLY." THE EXPLANTED DEVICES WERE NOT RETURNED FOR INVESTIGATION; THEREFORE NO SPECIFIC ANALYSIS CAN BE PERFORMED ON THEM. BASED ON THE AVAILABLE INFORMATION, WE CANNOT DETERMINE WITH CERTAINTY THE ROOT CAUSE FOR THE EVENT. THE CHECK OF MANUFACTURING CHARTS AND RAW MATERIAL CERTIFICATE HIGHLIGHTED NO PRE-EXISTING ANOMALIES ON COMPONENTS MANUFACTURED LOT. NR. LOT. 1002850 - STER. 1000146, THEREFORE WE CAN STATE THEY HAVE BEEN MANUFACTURED UP TO SPECIFICATIONS AND IN LINE WITH RELEVANT TESTS AND CHECKS. THIS EVENT IS CLASSIFIED AS NOT PRODUCT RELATED. PMS DATA ACCORDING TO LIMACORPORATE PMS DATA, THE REVISION RATE OF CEMENTED CUPS (FAMILY CODE: 5615/16/18/19/20/22/26.50.XXX) DUE TO DISLOCATION AND/OR LOOSENING IS ABOUT (B)(4). NO CORRECTIVE ACTIONS REQUIRED FOR THIS SPECIFIC CASE. LIMACORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR ISSUE.
HIP REVISION SURGERY DUE TO DISLOCATION, INSTABILITY AND PAIN. EXCESSIVE POLYETHYLENE ABRASION WAS REPORTED. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2022. THE PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2010. THE PATIENT IS MALE, 76 YEARS OLD, 96 KG. THIS EVENT OCCURRED IN CZECH REPUBLIC.
HIP REVISION SURGERY DUE TO DISLOCATION, INSTABILITY AND PAIN. EXCESSIVE POLYETHYLENE ABRASION WAS REPORTED. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2022. THE PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2010. THE PATIENT IS MALE, 76 YEARS OLD, 96 KG. THIS EVENT OCCURRED IN CZECH REPUBLIC.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 674615 | STAND. ACETAB. CEM. CUP Ø52MM | CEMENTED CUPS (UHMWPE) DIA. 52 FOR HEAD DIA28MM | LPH | LIMACORPORATE S.P.A. | 5618.50.040 | 1002850 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |