SMR REVERSE HUMERAL BODY SHORT
Report
- Report Number
- 3008021110-2024-00047
- Event Type
- Injury
- Date Received
- May 14, 2024
- Date of Event
- April 22, 2024
- Report Date
- July 11, 2024
- Manufacturer
- LIMACORPORATE S.P.A.
- Product Code
- PHX
- PMA / PMN Number
- K110598
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
INVESTIGATION CHECKING THE MANUFACTURING CHARTS OF THE LOT NUMBERS INVOLVED IN THE COMPLAINT, NO PRE-EXISTING ANOMALY HAS BEEN FOUND OUT. ACCORDING TO OUR RECORDS, AT LEAST 55 OUT OF 63 SMR REVERSE HUMERAL BODIES WITH LOT 2311935 AND STERILIZATION (B)(4) HAVE BEEN IMPLANTED AND THIS IS THE ONLY COMPLAINT RECEIVED ON THIS LOT NUMBER. NEITHER EXPLANTED COMPONENTS NOR X-RAYS WERE AVAILABLE TO BE RETRIEVED AND ANALYZED. THEREFORE, BASED ON THE FEW INFORMATION AVAILABLE, WE ARE NOT ABLE TO PERFORM ANY FURTHER INVESTIGATION. HOWEVER, ACCORDING TO THE INFORMATION RECEIVED BY THE COMPLAINT SOURCE, THE PATIENT HAS HAD A LONG HISTORY OF REVISION SURGERIES. THEREFORE, CONSIDERING THAT: - NO PRE-EXISTING ANOMALY HAS BEEN DISCOVERED BY CHECKING THE MANUFACTURING CHARTS OF THE LOT NUMBERS INVOLVED IN THE COMPLAINT - BASED ON THE INFORMATION RECEIVED, THE PATIENT HAS HAD A LONG HISTORY OF REVISION SURGERIES. WE CAN CONCLUDE THAT THE EVENT IS NOT PRODUCT RELATED. PMS DATA THE EVENT REPORTED BY COMPLAINT SOURCE IS THE REVISION OF A CUSTOM-MADE IMPLANT DUE TO INFECTION. NO REVISION RATE TO BE PROVIDED SINCE CUSTOMIZED IMPLANTS ARE MANUFACTURED AS SINGLE PIECES. CONSIDERING THE SMR REVERSE STANDARD COMPONENTS INVOLVED IN THE EVENT, ACCORDING TO OUR RECORD, THE OCCURRENCE RATE OF REVISION SURGERIES OF SMR REVERSE PROSTHESES DUE TO INFECTION IS AROUND 0.07%. BASED ON THE ANALYSIS PERFORMED AND ACCORDING TO THE RELEVANT PMS DATA, NO CORRECTIVE ACTIONS IS REQUIRED FOR THIS SPECIFIC CASE. LIMACORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR ISSUE. NOTE: THIS IS A FINAL REPORT.
INVESTIGATION CHECKING THE MANUFACTURING CHARTS OF THE LOT NUMBERS INVOLVED IN THE COMPLAINT, NO PRE-EXISTING ANOMALY HAS BEEN FOUND OUT. A FINAL MDR WILL BE SUBMITTED AS SOON AS THE INVESTIGATION IS COMPLETED.
SHOULDER WASHOUT SURGERY PERFORMED ON (B)(6) 2024, DUE TO INFECTION. THE SURGEON REQUESTED A NEW HP GLENOSPHERE FOR THE PATIENT. THE WASHOUT SURGERY HAS BEEN PERFORMED WITH THE FOLLOWING COMPONENTS IMPLANTED: - SMR REVERSE HUMERAL BODY SHORT (PART CODE 1352.15.005, LOT NUMBER 2311935, STERILIZATION (B)(4)) - SMR REVERSE HP LINER SHORT (PART CODE 1362.09.010, LOT NUMBER 2105016, STERILIZATION (B)(4)) - SMR CONNECTOR SMALL STD (PART CODE 1374.15.310, LOT NUMBER 2312074, STERILIZATION (B)(4)) - SMR REVERSE HP GLENOSPH. 44 MM (PART CODE 1374.50.440, LOT NUMBER 2313222, STERILIZATION (B)(4)) - CMD 23-1173 GLENOID IMPLANT (PART CODE 9618.14.0U5, LOT NUMBER 2314683, STERILIZATION (B)(4)). THE PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2024, AND DURING THIS SURGERY THE HEMI IMPLANT PREVIOUSLY IMPLANTED WAS REPLACED WITH A CUSTOM MADE IMPLANT. THE CLINICAL HISTORY OF THE PATIENT IS SUMMARIZED AS FOLLOWS: - THE PATIENT HAD A SEVERE FRACTURE OF THE HUMERAL BONE IN 2018. - PRIMARY SURGERY WITH LIMACORPORATE COMPONENTS PERFORMED ON (B)(6) 2022 (SMR REVERSE COMPONENTS IMPLANTED) - FIRST REVISION SURGERY PERFORMED ON (B)(6) 2022, DUE TO IMPLANT DISLOCATION (NEW SMR REVERSE COMPONENTS IMPLANTED). THIS REVISION SURGERY IS REGISTERED AS INTERNAL COMPLAINT (B)(4) AND REPORTED TO THE FDA WITH MFR 3008021110-2022-00111. - ON (B)(6) 2022, THE PATIENT PRESENTED WITH PAIN AFTER POST OP EXERCISES. X-RAY SHOWED DISLOCATION AND SIGNS OF IMPLANT LOOSENING. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 (NEW SMR REVERSE COMPONENTS IMPLANTED). THIS REVISION SURGERY IS REGISTERED AS INTERNAL COMPLAINT (B)(4) AND REPORTED TO THE FDA WITH MFR 3008021110-2022-00110. - ON (B)(6) 2022, DURING FOLLOW UP VISIT THE PATIENT PRESENTED WITH SHOULDER DISLOCATION AND PAIN. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 (SMR REVERSE HP GLENOSPHERE IMPLANTED, PART CODE 1374.50.440, FDA COMPASSIONATE USE U220598 / LIMA CASE 22-1376). THIS EVENT IS REGISTERED AS INTERNAL COMPLAINT 20220332 AND REPORTED TO THE FDA WITH MFR 3008021110-2022-00139) - THE PATIENT DISLOCATED SHORTLY FOLLOWING THE SURGERY AND AS OF (B)(6) 2023, A 44MM ECCENTRIC/CORRECTIVE SMR REVERSE HP GLENOSPHERE NEEDED TO BE PLACED (PART CODE 1374.50.444). THIS EVENT IS REGISTERED AS INTERNAL COMPLAINT (B)(4) AND REPORTED TO THE FDA WITH THE SUPPLEMENT SUBMISSION FOR FDA COMPASSIONATE USE U220598 / LIMA CASE 22-1376. - X-RAYS TAKEN ON (B)(6) 2023, SHOWED THE PROSTHESIS TO BE DISLOCATED. THE REVISION SURGERY TOOK PLACE ON (B)(6) 2023, AND THE SMR REVERSE HP GLENOSPHERE (PART CODE 1374.50.444) HAS BEEN REPLACED BY A HEMIARTHROPLASTY (ANATOMIC). THIS EVENT IS REGISTERED AS INTERNAL COMPLAINT (B)(4), NOT REPORTED TO THE FDA (EVENT CAUSED BY PATIENT CONDITION). - X-RAYS TAKEN ON (B)(6) 2023, SHOWED THAT THE HEMIARTHROPLASTY (ANATOMIC) IS DISLOCATED. THE REVISION SURGERY TOOK PLACE ON (B)(4) 2024, AND THE CUSTOM MADE COMPONENT CMD 23-1173 HAS BEEN IMPLANTED. THIS EVENT IS REGISTERED AS INTERNAL COMPLAINT 20240103 AND REPORTED TO THE FDA WITH MFR 3008021110-2024-00043. - THE WASHOUT SURGERY WAS PERFORMED ON (B)(6) 2024, DUE TO INFECTION OF THE CUSTOM MADE COMPONENT CMD 23-1173 (HEREBY REPORTED). THE PATIENT IS A MALE, DATE OF BIRTH (B)(4) 1964. EVENT HAPPENED IN THE UNITED STATES.
SHOULDER WASHOUT SURGERY PERFORMED ON (B)(6) 2024, DUE TO INFECTION. THE SURGEON REQUESTED A NEW HP GLENOSPHERE FOR THE PATIENT. THE WASHOUT SURGERY HAS BEEN PERFORMED WITH THE FOLLOWING COMPONENTS IMPLANTED: SMR REVERSE HUMERAL BODY SHORT (PART CODE 1352.15.005, LOT NUMBER 2311935, STERILIZATION 2300145) SMR REVERSE HP LINER SHORT (PART CODE 1362.09.010, LOT NUMBER 2105016, STERILIZATION 2100144) SMR CONNECTOR SMALL STD (PART CODE 1374.15.310, LOT NUMBER 2312074, STERILIZATION 2300138) SMR REVERSE HP GLENOSPH. 44 MM (PART CODE 1374.50.440, LOT NUMBER 2313222, STERILIZATION 2300130) CMD 23-1173 GLENOID IMPLANT (PART CODE 9618.14.0U5, LOT NUMBER 2314683, STERILIZATION 2300138). THE PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2024, AND DURING THIS SURGERY THE HEMI IMPLANT PREVIOUSLY IMPLANTED WAS REPLACED WITH A CUSTOM MADE IMPLANT. THE CLINICAL HISTORY OF THE PATIENT IS SUMMARIZED AS FOLLOWS: THE PATIENT HAD A SEVERE FRACTURE OF THE HUMERAL BONE IN 2018. PRIMARY SURGERY WITH LIMA CORPORATE COMPONENTS PERFORMED ON (B)(6) 2022 (SMR REVERSE COMPONENTS IMPLANTED) FIRST REVISION SURGERY PERFORMED ON (B)(6) 2022, DUE TO IMPLANT DISLOCATION (NEW SMR REVERSE COMPONENTS IMPLANTED). THIS REVISION SURGERY IS REGISTERED AS INTERNAL COMPLAINT (B)(4) AND REPORTED TO THE FDA WITH MFR 3008021110-2022-00111. ON (B)(6) 2022, THE PATIENT PRESENTED WITH PAIN AFTER POST OP EXERCISES. X-RAY SHOWED DISLOCATION AND SIGNS OF IMPLANT LOOSENING. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 (NEW SMR REVERSE COMPONENTS IMPLANTED). THIS REVISION SURGERY IS REGISTERED AS INTERNAL COMPLAINT (B)(4) AND REPORTED TO THE FDA WITH MFR 3008021110-2022-00110 ON (B)(6) 2022, DURING FOLLOW UP VISIT THE PATIENT PRESENTED WITH SHOULDER DISLOCATION AND PAIN. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 (SMR REVERSE HP GLENOSPHERE IMPLANTED, PART CODE 1374.50.440, FDA COMPASSIONATE USE (B)(4) / LIMA CASE (B)(4) . THIS EVENT IS REGISTERED AS INTERNAL COMPLAINT (B)(4) AND REPORTED TO THE FDA WITH MFR 3008021110-2022-00139) THE PATIENT DISLOCATED SHORTLY FOLLOWING THE SURGERY AND AS OF (B)(6) 2023, A 44MM ECCENTRIC/CORRECTIVE SMR REVERSE HP GLENOSPHERE NEEDED TO BE PLACED (PART CODE 1374.50.444). THIS EVENT IS REGISTERED AS INTERNAL COMPLAINT (B)(4) AND REPORTED TO THE FDA WITH THE SUPPLEMENT SUBMISSION FOR FDA COMPASSIONATE USE (B)(4) / LIMA CASE (B)(4) . X-RAYS TAKEN ON (B)(6) 2023, SHOWED THE PROSTHESIS TO BE DISLOCATED. THE REVISION SURGERY TOOK PLACE ON (B)(6) 2023, AND THE SMR REVERSE HP GLENOSPHERE (PART CODE 1374.50.444) HAS BEEN REPLACED BY A HEMIARTHROPLASTY (ANATOMIC). THIS EVENT IS REGISTERED AS INTERNAL COMPLAINT (B)(4) NOT REPORTED TO THE FDA (EVENT CAUSED BY PATIENT CONDITION). X-RAYS TAKEN ON (B)(6) 2023, SHOWED THAT THE HEMIARTHROPLASTY (ANATOMIC) IS DISLOCATED. THE REVISION SURGERY TOOK PLACE ON (B)(6) 2024, AND THE CUSTOM MADE COMPONENT CMD (B)(4) HAS BEEN IMPLANTED. THIS EVENT IS REGISTERED AS INTERNAL COMPLAINT (B)(4) AND REPORTED TO THE FDA WITH MFR 3008021110-2024-00043. THE WASHOUT SURGERY WAS PERFORMED ON (B)(6) 2024, DUE TO INFECTION OF THE CUSTOM MADE COMPONENT CMD (B)(4) (HEREBY REPORTED). THE PATIENT IS A MALE, DATE OF BIRTH (B)(6) 1964. EVENT HAPPENED IN THE UNITED STATES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 775991 | SMR REVERSE HUMERAL BODY SHORT | SHORT REVERSE HUMERAL BODY (INVERSION ONLY) | PHX | LIMACORPORATE S.P.A. | 1352.15.005 | 2311935 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |