LINER F. MET.BACK GLEN.SMALL-R
Report
- Report Number
- 3008021110-2022-00114
- Event Type
- Injury
- Date Received
- November 7, 2022
- Date of Event
- March 17, 2021
- Report Date
- August 1, 2024
- Manufacturer
- LIMACORPORATE S.P.A.
- Product Code
- KWS
- PMA / PMN Number
- K113254
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
BY THE CHECK OF THE DEVICE HISTORY, NO PRE-EXISTING ANOMALY WAS DETECTED ON THE 67 LINERS RELEASED WITH LOT N. 19AT0TQ, STER. 1900245. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THIS LOT NUMBER. A FINAL REPORT WILL BE SUBMITTED AFTER THE CONCLUSION OF THE INVESTIGATION.
BY THE CHECK OF THE DEVICE HISTORY RECORDS AND RAW MATERIALS OF THE POLYETHYLENE LINER WITH CODE 1377.50.005, LOT. 19AT0TQ - STER. (B)(4), NO PRE-EXISTING ANOMALY WAS DETECTED, THUS WE CAN STATE THAT THE (B)(4) PIECES WITH THIS LOT NUMBER HAD BEEN MANUFACTURED UP TO DRAWING SPECIFICATIONS AND IN LINE WITH THE RELEVANT CHECKS. ACCORDING TO OUR RECORDS, AT LEAST (B)(4) WITH LOT. 19AT0TQ - STER. (B)(4) HAVE BEEN IMPLANTED AND THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THIS LOT NUMBER. EVEN THOUGH REQUESTED THE FOLLOWING WERE NOT PROVIDED TO LIMACORPORATE: - PRE- AND POST- OPERATIVE X-RAYS OF THE PRIMARY SURGERY; - PRE- AND POST-OPERATIVE X-RAYS OF THE REVISION SURGERY; - BROKEN PROSTHESIS EXPLANTED; - PRESENCE OF TRAUMATIC EVENT; - SOME PHYSICAL INFORMATION ABOUT THE PATIENT, USEFUL FOR THE INVESTIGATION, SUCH AS, WEIGHT, HEIGHT, LIFESTYLE. THE DEVICES INVOLVED WERE ANALYZED BY AN INDEPENDENT EXTERNAL LABORATORY. THE EXPERT COULD NOT DETERMINE THE CAUSE RESPONSIBLE FOR THE BREAKAGE OF THE ANCHORAGE PIN AND AT WHAT MOMENT AFTER THE IMPLANTATION THIS EVENT OCCURRED LEADING TO FAILURE OF THE PROTHESIS, AS THE LINER CAME LOOSE FROM THE METAL BACK OF THE GLENOID FOLLOWING THE LOSS OF THE CENTRAL ANCHORAGE AND THEN MOVED FREELY IN THE JOINT. IN CONCLUSION, THE ROOT CAUSE OF THE REPORTED FAILURE CANNOT BE DETERMINED WITH CERTAINTY, CONSIDERING THAT: - NO ANOMALIES THAT COULD HAVE CONTRIBUTED TO THE EVENT WERE DETECTED BY CHECKING THE DHRS AND RAW MATERIALS OF THE INVOLVED POLYETHYLENE LINER WITH CODE 1377.50.005, LOT NUMBER 19AT0TQ. - THE EXPERT COULD NOT DETERMINE THE CAUSE RESPONSIBLE FOR THE BREAKAGE OF LINER ANCHORAGE PIN, WHICH LED TO LINER LOOSENING AND IMPLANT FAILURE. WE MAY CLASSIFY THIS EVENT AS NOT PRODUCT RELATED. PMS DATA: ACCORDING TO LIMACORPORATE PMS DATA, THE REVISION RATE OF L1 LINERS - BELONGING TO THE FAMILY CODES 1377.50.0XX - DUE TO BREAKAGE IS AROUND (B)(4). BASED ON THE ROOT CAUSE ANALYSIS PERFORMED AND ACCORDING TO THE RELEVANT PMS DATA, NO CORRECTIVE ACTIONS REQUIRED FOR THIS SPECIFIC CASE. LIMACORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR ISSUE. THIS IS AN MDR FINAL REPORT.
SHOULDER REVISION SURGERY PERFORMED ON (B)(6) 2021, DUE TO BREAKAGE OF THE POLYETHYLENE LINER WITH CODE 1377.50.005, LOT N. 19AT0TQ, STER. 1900245. THE PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2019. THE COMPLAINT SOURCE REPORTED THAT THE SYNOVIAL MEMBRANE SHOWED A DISTINCT BLACKISH DISCOLORATION CORRESPONDING TO METALLOSIS. THIS EVENT OCCURRED IN GERMANY.
SHOULDER REVISION SURGERY PERFORMED ON (B)(6) 2021, DUE TO BREAKAGE OF THE POLYETHYLENE LINER WITH CODE 1377.50.005, LOT N. 19AT0TQ, STER. (B)(4). THE PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2019. THE COMPLAINT SOURCE REPORTED THAT THE POLYETHYLENE PIN THAT LOCKS INTO THE METAL BACK APPEARED TO BE BROKEN. THE SYNOVIAL MEMBRANE SHOWED A DISTINCT BLACKISH DISCOLORATION CORRESPONDING TO METALLOSIS. DATE OF BIRTH: (B)(6) 1963. THIS EVENT OCCURRED IN GERMANY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 182386 | LINER F. MET.BACK GLEN.SMALL-R | LINER FOR METAL-BACK (UHMWPE) LINER SMALL-R | KWS | LIMACORPORATE S.P.A. | 1377.50.005 | 19AT0TQ |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |