DELTA TT PRO D.52MM
Report
- Report Number
- 3008021110-2022-00055
- Event Type
- Malfunction
- Date Received
- July 8, 2022
- Date of Event
- June 13, 2022
- Report Date
- January 17, 2024
- Manufacturer
- LIMACORPORATE S.P.A.
- Product Code
- MBL
- PMA / PMN Number
- K182099
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
BY CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT#, NO PRE-EXISTING ANOMALY WAS FOUND ON A TOTAL OF 9 ACETABULAR CUPS MANUFACTURED WITH THE SAME LOT#. NO OTHER COMPLAINTS RECEIVED ON THE SAME LOT# (2125579). WE WILL SEND A FINAL INCIDENT REPORT ONCE THE INVESTIGATION WILL BE CONCLUDED.
INVESTIGATION BY CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT NUMBER, NO PRE-EXISTING ANOMALY WAS FOUND ON A TOTAL OF 9 ACETABULAR CUPS MANUFACTURED WITH THE SAME LOT NUMBER. ACCORDING TO OUR RECORDS, ON A TOTAL OF 9 ACETABULAR CUPS MANUFACTURED WITH THE LOT NUMBER INVOLVED IN THIS COMPLAINT, A TOTAL OF 8 PIECES HAVE BEEN IMPLANTED, AND THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THE SAME LOT NUMBER (2125579). X-RAYS AND EXPLANTS ANALYSIS NEITHER PRE-OPERATIVE X-RAYS NOR POST-OPERATIVE ONES ARE AVAILABLE TO BE SHARED FOR INVESTIGATION. HOWEVER, THE EXPLANTED COMPONENT HAS BEEN RETURNED AND IT HAS BEEN ANALYSED INTERNALLY. LIMACORPORATE RECEIVED THE ACETABULAR CUP ONLY. FROM THE VISUAL ANALYSIS OF THE RETURNED DEVICE, WE CAN SUPPOSE THAT DURING THE INSERTION OF THE LINER IT MAY HAVE BEEN HIT TOO VIGOROUSLY, OR IT MAY HAVE CROSSED AND THEREFORE DEFORMED, CAUSING THE IMPOSSIBILITY OF REMOVAL. THEREFORE, BASED ON THE FEW INFORMATION RECEIVED: NO PRE-EXISTING ANOMALY WAS FOUND BY CHECKING THE MANUFACTURING CHARTS OF THE LOT NUMBER INVOLVED IN THE COMPLAINT. THE INTERNAL INVESTIGATION LED TO THE CONCLUSION THAT THE LINER MAY HAVE BEEN HIT TO VIGOROUSLY, OR IT MAY HAVE CROSSED, AND THIS CIRCUMSTANCE CAUSED THE LINER TO GET STUCK IN THE ACETABULAR CUP. WE CAN SUPPOSE THAT THE ISSUE WAS NOT PRODUCT RELATED. PMS DATA: ACCORDING TO THE RELEVANT PMS DATA AND CONSIDERING THE DELTA TT PRO ACETABULAR CUP BELONGING TO THE FAMILY CODES 5553.14.XXX, THE OCCURRENCE RATE OF SIMILAR ISSUES IS AROUND (B)(4). NO CORRECTIVE ACTIONS ARE REQUIRED FOR THIS SPECIFIC CASE. LIMACORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR ISSUE. THIS IS A FINAL MDR.
INTRA-OP ISSUE EXPERIENCED ON (B)(6) 2022: WHILE DOING A TRIAL REDUCTION DURING A TOTAL HIP REPLACEMENT, THE TRIAL LINER (PRODUCT INFO NOT AVAILABLE) GOT STUCK INSIDE THE ACETABULAR IMPLANT. ACCORDING TO THE COMPLAINT SOURCE, THE SURGEON TRIED TO SOLVE THE SEIZURE BY REMOVING THE ALREADY IMPLANTED DELTA TT PRO ACETABULAR CUP - PRODUCT CODE (B)(4), LOT 2125579. UNFORTUNATELY, EVEN AFTER EVERYTHING CAME OUT, THE SURGEON WAS UNABLE TO REMOVE THE TRIAL LINER AND HAD TO IMPLANT A SECOND 52MM ACETABULAR CUP CAUSING A TOTAL OF 60 MINUTES OF PROLONGED SURGERY TIME. EVENT HAPPENED IN US.
INTRA-OP ISSUE EXPERIENCED ON (B)(6) 2022: WHILE DOING A TRIAL REDUCTION DURING A TOTAL HIP REPLACEMENT, THE TRIAL LINER (PRODUCT INFO NOT AVAILABLE) GOT STUCK INSIDE THE ACETABULAR IMPLANT. ACCORDING TO THE COMPLAINT SOURCE, THE SURGEON TRIED TO SOLVE THE SEIZURE BY REMOVING THE ALREADY IMPLANTED DELTA TT PRO ACETABULAR CUP - PRODUCT CODE 5553.14.523, LOT 2125579, STERILIZATION 2200016. UNFORTUNATELY, EVEN AFTER EVERYTHING CAME OUT, THE SURGEON WAS UNABLE TO REMOVE THE TRIAL LINER AND HAD TO IMPLANT A SECOND 52 MM ACETABULAR CUP CAUSING A TOTAL OF 60 MINUTES OF PROLONGED SURGERY TIME. EVENT HAPPENED IN UNITED STATES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2087398 | DELTA TT PRO D.52MM | DELTA TT PRO ACETABULAR CUP | MBL | LIMACORPORATE S.P.A. | 5553.14.523 | 2125579 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |