DELTA-TT ACETABULAR CUP Ø54 MM
Report
- Report Number
- 3008021110-2021-00065
- Event Type
- Injury
- Date Received
- August 26, 2021
- Date of Event
- July 30, 2021
- Report Date
- November 25, 2021
- Manufacturer
- LIMACORPORATE S.P.A.
- Product Code
- LPH
- PMA / PMN Number
- K112898
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
BY CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT #2000382, NO PRE-EXISTING ANOMALY WAS FOUND ON A TOTAL OF (B)(4) ITEMS MANUFACTURED WITH THE SAME LOT #. ACCORDING TO OUR RECORDS, AT LEAST (B)(4) CUPS WITH LOT #2000382 - STER. 2000105 HAVE BEEN IMPLANTED AND THIS IS THE ONLY COMPLAINT RECEIVED ON THIS LOT #. NO ADDITIONAL DETAILS WERE AVAILABLE ON THIS POST-OPERATIVE ISSUE, SPECIFICALLY THE FOLLOWING INFORMATION WAS REQUESTED TO THE COMPLAINT SOURCE, BUT IT WAS NOT AVAILABLE: · PRE-OPERATIVE X-RAYS RELATED TO THE REVISION SURGERY; · POST-OPERATIVE X-RAYS RELATED TO PREVIOUS SURGERY; · EXPLANTED COMPONENTS. BASED ON THE VERY FEW INFORMATION RECEIVED, WE ARE NOT ABLE TO FURTHER INVESTIGATE THE ROOT CAUSE OF THE EVENT. HOWEVER, CONSIDERING THAT THE CHECK OF THE MANUFACTURING CHARTS HIGHLIGHTED NO ANOMALIES ON THE TOTAL NUMBER OF COMPONENTS MANUFACTURED WITH LOT #2000382, WE CAN STATE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA. ACCORDING TO LIMACORPORATE PMS DATA, REVISION RATE OF DELTA TT CUPS - BELONGING TO THE FAMILY CODES 5552.15.XXX - DUE TO PAIN IS 0.009%. 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. NOTE: THIS IS A FINAL MDR.
HIP REVISION SURGERY PERFORMED ON (B)(6) 2021, DUE TO PATIENT EXPERIENCING GROIN PAIN. IT WAS REPORTED A LIKELY PSOAS PAIN AS THE RIM OF THE DELTA-TT ACETABULAR CUP Ø54 MM (PRODUCT CODE 5552.15.540, LOT #2000382 - STER. 2000105) SITTING UP WAS POTENTIALLY CAUSING IRRITATION. ACCORDING TO THE COMPLAINT SOURCE, THE OFFSET WAS LARGE, AND THE CUP WAS WELL FIXED. THE FOLLOWING COMPONENTS WERE REMOVED AND REPLACED: · DELTA-TT ACETABULAR CUP Ø54 MM (PRODUCT CODE 5552.15.540, LOT #2000382 - STER. 2000105). · DELTA PROTRUDED LINER ØINT 32MM #L (PRODUCT CODE 5886.54.160, LOT #1914584 - STER. 1900407) - PRODUCT NOT SOLD IN THE US. · BONE SCREW Ø6,5 H.25MM (PRODUCT CODE 8420.15.020, LOT #2005820 - STER. 2000186). · BONE SCREW Ø6,5 H.35MM (PRODUCT CODE 8420.15.040, LOT #1907881 - STER. 1900203). · FEMORAL MODULAR HEAD - M Ø32MM (PRODUCT CODE 5010.09.322, LOT #2003184 - STER. 2000155). PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2020. PATIENT IS A MALE, 66 YEARS OLD. IT WAS REPORTED HIS BMI IS AROUND 30. EVENT HAPPENED IN NEW ZEALAND.
BY CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT #, NO PRE-EXISTING ANOMALY WAS FOUND ON THE COMPONENTS PLACED ON THE MARKET WITH THE SAME LOT #. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THIS LOT #. WE WILL SUBMIT A FINAL MDR ONCE THE INVESTIGATION WILL BE COMPLETED.
HIP REVISION SURGERY PERFORMED ON (B)(6) 2021, DUE TO PATIENT EXPERIENCING GROIN PAIN AND LIKELY PSOAS PAIN. ACCORDING TO THE COMPLAINT SOURCE, THE OFFSET IS LARGE AS WELL. THE DELTA-TT ACETABULAR CUP Ø54 MM (PRODUCT CODE 5552.15.540, LOT #2000382 - STER. 2000105) CUP WAS REMOVED AND A NEW ONE WAS IMPLANTED. IT WAS REPORTED THAT THE CUP WAS WELL FIXED. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2020. PATIENT IS A MALE, (B)(6) YEARS OLD. EVENT HAPPENED IN (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1267924 | DELTA-TT ACETABULAR CUP Ø54 MM | ACETABULAR CUPS (TI6AL4V) DIA. 54MM FOR LINER SIZE LARGE | LPH | LIMACORPORATE S.P.A. | 5552.15.540 | 2000382 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |