LOCK SELF-CENTERING HEAD Ø47
Report
- Report Number
- 3008021110-2022-00078
- Event Type
- Injury
- Date Received
- September 19, 2022
- Date of Event
- August 10, 2022
- Report Date
- October 9, 2023
- 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
CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOTS #2081736 AND #1908479, NO PRE-EXISTING ANOMALY WAS FOUND ON THE COMPONENTS MANUFACTURED WITH THE SAME LOT #S. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THESE LOT #S. WE WILL SUBMIT A FINAL MDR AS SOON AS THE INVESTIGATION IS COMPLETED.
CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT #2081736, NO PRE-EXISTING ANOMALY WAS FOUND ON A TOTAL OF 100 DEVICES MANUFACTURED WITH THE SAME LOT #. ACCORDING TO OUR RECORDS, AT LEAST 90 OUT OF 100 FEMORAL HEADS WITH LOT #2081736 - STER.2000083 HAVE BEEN IMPLANTED AND THIS IS THE ONLY COMPLAINT RECEIVED ON THIS LOT #. CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT #1908479, NO PRE-EXISTING ANOMALY WAS FOUND ON A TOTAL OF 23 DEVICES MANUFACTURED WITH THE SAME LOT #. ACCORDING TO OUR RECORDS, AT LEAST 19 OUT OF 23 LOCK SELF-CENTERING HEADS WITH LOT #1908479 - STER. 1900199 HAVE BEEN IMPLANTED AND THIS IS THE ONLY COMPLAINT RECEIVED ON THIS LOT #. DEVICE ANALYSIS THE ITEMS INVOLVED WERE RETURNED TO LIMACORPORATE FOR FURTHER ANALYSIS. VISUAL INSPECTION OF THE DEVICES SHOWS THAT NO SIGNS OF WEAR ARE VISIBLE ON THE INNER AND OUTER SURFACE OF THE LINER AND OF THE C-RING OF THE LOCK SELF-CENTERING HEAD. DIFFERENTLY, SOME SCRATCHES ARE VISIBLE ON THE SURFACE AND ON THE EDGE OF THE COCRMO LOCK CUP OF THE LOCK SELF-CENTERING HEAD. THE INNER AND OUTER SURFACE OF THE RETURNED FEMORAL HEAD PRESENTS SCRATCHES AND SIGNS OF WEAR. ON THE EXTERNAL SURFACE OF THE UHMWPE LINER A SMALL DEFORMATION IS OBSERVED THROUGHOUT THE HEIGHT OF THE ITEM. THE DEFORMATION IS COMPATIBLE WITH THE GROOVE ON THE INTERNAL SURFACE OF THE COCRMO LOCK CUP THAT IS INTENDED FOR AIR LEAKING. THE PRESENCE OF THE DEFORMATION ON THE OUTER SURFACE OF THE LINER PROVES THAT IT PROPERLY COUPLED TO THE CUP, IT DIDN'T GET LOOSENED AND STAYED STABLY COUPLED TO IT, AS NO SIGNS OF WEAR ARE THERE VISIBLE. A FUNCTIONAL ANALYSIS WAS PERFORMED ON THE RETURNED LINER, C-RING, COCRMO CUP AND FEMORAL HEAD TO COUPLE THEM TOGETHER. THE PIECES CANNOT COUPLE TOGETHER AS INTENDED AS THE FEMORAL HEAD DOESN'T PROPERLY SEAT ON THE LINER AND THE C-RING CANNOT BE CONNECTED TO LOCK THE ASSEMBLY. MOREOVER, THE LINER MOVES FREELY INSIDE THE CUP. A DIMENSIONAL ANALYSIS WAS PERFORMED ON THE LINER AND C-RING OF THE LOCK SELF-CENTERING HEAD Ø47 (PRODUCT CODE 5527.09.470, LOT #1908479) AND IT REVEALED THAT THE TWO SUBCOMPONENTS ARE OUT OF THE SPECIFICS. THESE PARTS ARE MADE OF UHMWPE (ULTRA-HIGH MOLECULAR WEIGHT POLYETHYLENE) AND THUS SLIGHTLY DEFORM WHEN CLEANED AND STERILIZED. IN RESPECT TO THE EXPECTED MEASUREMENTS, BOTH LINER AND C-RING GOT WIDENED ON HEIGHT AND NARROWED ON THE DIAMETER. BEFORE SHIPMENT, THE DEVICES WERE STEAM STERILIZED BY THE HOSPITAL AT 125°C FOR 15 MINUTES ACCORDING TO THE DECONTAMINATION PROCEDURE AND RECEIVED DOCUMENTS (NO INFORMATION WAS AVAILABLE ON THE TECHNICAL SETTINGS OF THE STERILIZATION EQUIPMENT NOR ON THE DETERGENTS USED). STERILIZATION TESTS WERE PERFORMED ON A LINER AND A C-RING BELONGING TO THE SAME LOT #S OF THE ONES INVOLVED IN THE COMPLAINT. THE DIMENSIONAL CHECKS PERFORMED ON THEM BEFORE THE TESTS PROVED THAT THEY ARE COMPLIANT TO THE DRAWING SPECIFICS. THE DEVICES STERILIZED USING PARAMETERS SIMILAR TO THE ONES REPORTED BY THE HOSPITAL WERE STILL WITHIN THE SPECIFICS, BUT THE DEVICES TESTED AT 150°C FOR 15 MINUTES WERE OUT OF THE SPECIFICS, AND THE OBSERVED DEFORMATIONS WERE CLOSER IN RANGE TO THE ONES FOUND ON THE RETURNED DEVICES. THEREFORE, THE DEFORMATION OBSERVED ON THE RETURNED PRODUCTS CAN BE EXPLAINED BY AN AGGRESSIVE STERILIZATION PERFORMED ON THEM AFTER EXPLANTING. X-RAYS ANALYSIS LIMACORPORATE RECEIVED A TOTAL OF TWO X-RAYS AND ONE CT SCANS REFERRING TO PRE-OPERATIVE OF THE LAST REVISION SURGERY, AND ONE CT SCAN REFERRING TO PRE-OPERATIVE OF THE PRIMARY SURGERY. THE X-RAYS RECEIVED - DATED (B)(6) 2022 AND EARLY (B)(6) 2022 WHEN THE DISLOCATION WAS DISCOVERED - AND THE CT SCANS - DATED (B)(6) 2019 AND (B)(6) 2022 - HAVE BEEN EVALUATED BY A MEDICAL CONSULTANT. FOLLOWING, THE MEDICAL CONSULTANT COMMENTS: "[...] DISLOCATIONS OF THE WHOLE BIPOLAR ARE NOT UNUSUAL BUT IN THAT CASE THE METAL PART REMAINED IN THE ACETABULAR WHILE THE HEAD DISLOCATED FROM THE LINER. WHEN YOU SAY THE EXAMINATION OF THE POLY COMPONENTS DOES NOT SHOW ANY DAMAGE AND THE LOCKING MECHANISM WAS INTACT, I ONLY CAN SUSPECT THAT THE SURGEON IN BOTH REVISIONS WAS NOT ABLE TO ASSEMBLE THE COMPONENTS CORRECTLY... ON THE ONE X-RAY(B)(6) THE HEAD APPEARS UNUSUALLY DEEP IN THE METAL SHELL. IMPINGEMENT MIGHT HAVE OCCURRED BUT THAT SHOULD HAVE LEFT MARKS ON THE POLY. A LATERAL VIEW COULD CLEAR, WHETHER IT HAS BEEN INSIDE AT ALL". CONSIDERING THAT: · CHECK OF THE MANUFACTURING CHARTS HIGHLIGHTED NO ANOMALIES ON THE COMPONENTS MANUFACTURED WITH LOTS #2081736 AND #1908479; · ACCORDING TO THE MEDICAL CONSULTANT "[...] I ONLY CAN SUSPECT THAT THE SURGEON IN BOTH REVISIONS WAS NOT ABLE TO ASSEMBLE THE COMPONENTS CORRECTLY... ON THE ONE X-RAY (B)(6) THE HEAD APPEARS UNUSUALLY DEEP IN THE METAL SHELL. IMPINGEMENT MIGHT HAVE OCCURRED BUT THAT SHOULD HAVE LEFT MARKS ON THE POLY [...]"; · ACCORDING TO THE TESTS, AN AGGRESSIVE STERILIZATION WAS PERFORMED ON THE EXPLANTS AND THE UHMWPE GOT DEFORMED SO THAT THEY FAILED THE DIMENSIONAL AND FUNCTIONAL TESTS; · NO SIGNS OF WEAR NOR SCRATCHES ARE PRESENT ON THE SURFACE OF THE LINER AND C-RING, INDICATING THAT THE DEVICES HAD BEEN PROPERLY IN PLACE IN SITU; THE PRESENCE OF THE GROOVE ON THE OUTER SURFACE OF THE LINER PROVES THAT THE DEVICE PROPERLY COUPLED TO THE COCRMO LOCK CUP IN SITU, STAYED IN PLACE AND REMAINED FIRMLY COUPLED TO THE CUP; WE CANNOT GO BACK WITH CERTAINTY TO THE ROOT CAUSE OF THE EVENT, WE CAN HYPOTHESIZE THAT THE C-RING WASN'T PROPERLY CONNECTED, EVENTUALLY LEADING TO THE REPORTED DISASSEMBLY. STILL, WE STATE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA ACCORDING TO LIMACORPORATE PMS DATA, REVISION RATE OF LOCK SELF-CENTERING HEADS - BELONGING TO THE FAMILY CODES 5527.09.XXX AND 5527.05.XXX - DUE TO DISASSEMBLY IS 0.01%. 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.
REVISION SURGERY OF A HIP PROSTHESIS PERFORMED ON (B)(6), 2022, DUE TO DISASSEMBLY OF THE FEMORAL MODULAR HEAD - S Ø28MM (PRODUCT CODE 5010.42.281, LOT #2081736 - STER.2000083) FROM THE LOCK BIPOLAR SELF-CENTERING HEAD Ø47 (PRODUCT CODE 5527.09.470, LOT #1908479 - STER. 1900199). ACCORDING TO THE RECEIVED INFORMATION, IN EARLY (B)(6) 2022 THE PATIENT WAS UNABLE TO WALK AND THE DISLOCATION OF THE IMPLANT WAS FOUND. PATIENT IS A FEMALE, 87 YEARS OLD. IT WAS REPORTED SHE HAS HYPOACUSIA AND GOES TO SEE A DOCTOR TO DIAGNOSE FOR AGE-RELATED FORGETFULNESS OR DEMENTIA. SHE'S SLIGHTLY OBESE. HISTORY OF HIP SURGERIES IS THE FOLLOWING: PRIMARY SURGERY PERFORMED ON (B)(6), 2019; FIRST REVISION SURGERY PERFORMED ON (B)(6), 2020, DUE TO DISLOCATION OF THE FEMORAL HEAD FROM THE LOCK BIPOLAR HEAD. THE EVENT WAS REGISTERED AS COMPLAINT #161/20, AND REPORTED TO THE FDA BY MFR #3008021110-2020-00052; SECOND REVISION SURGERY PERFORMED ON (B)(6) 2022, DUE TO DISASSEMBLY OF THE COMPONENTS (HEREBY REPORTED). EVENT HAPPENED IN JAPAN.
REVISION SURGERY OF A HIP PROSTHESIS PERFORMED ON (B)(6) 2022, DUE TO DISASSEMBLY OF THE FEMORAL MODULAR HEAD; S Ø28MM (PRODUCT CODE 5010.42.281, LOT #2081736; STER.2000083) FROM THE LOCK SELF-CENTERING HEAD Ø47 (PRODUCT CODE 5527.09.470, LOT #1908479 - STER. 1900199). ACCORDING TO THE RECEIVED INFORMATION, IN EARLY AUGUST 2022 THE PATIENT WAS UNABLE TO WALK, AND THE DISLOCATION OF THE IMPLANT WAS FOUND. PATIENT IS A FEMALE, 87 YEARS OLD. IT WAS REPORTED SHE HAS HYPOACUSIA AND GOES TO SEE A DOCTOR TO DIAGNOSE FOR AGE RELATED FORGETFULNESS OR DEMENTIA. SHE'S SLIGHTLY OBESE. HISTORY OF HIP SURGERIES IS THE FOLLOWING: PRIMARY SURGERY PERFORMED ON (B)(6) 2019; FIRST REVISION SURGERY PERFORMED ON (B)(6) 2020, DUE TO DISLOCATION OF THE FEMORAL HEAD FROM THE LOCK BIPOLAR HEAD. PATIENT HAD A FALL. THE EVENT WAS REGISTERED AS COMPLAINT #161/20, AND REPORTED TO THE FDA BY MFR #3008021110-2020-00052; - SECOND REVISION SURGERY PERFORMED ON (B)(6) 2022, DUE TO DISASSEMBLY OF THE COMPONENTS (HEREBY REPORTED). EVENT HAPPENED IN JAPAN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 371717 | LOCK SELF-CENTERING HEAD Ø47 | LOCK BIPOLAR HEADS (COCRMO + UHMWPE LINER) DIA. 47 FOR HEAD DIA. 28 MM | LPH | LIMACORPORATE S.P.A. | 5527.09.470 | 1908479 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |