LPS CEMENTED STEM 13X125MM STR
Report
- Report Number
- 1818910-2025-02948
- Event Type
- Injury
- Date Received
- February 24, 2025
- Manufacturer
- DEPUY ORTHOPAEDICS INC US
- Product Code
- JWH
- UDI-DI
- 10603295079187
- PMA / PMN Number
- K033959
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- 003
Narratives
DEPUY ORTHOPAEDICS IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY ORTHOPAEDICS HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY ORTHOPAEDICS OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY ORTHOPAEDICS, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. ADDITIONAL NARRATIVE: IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: IT WAS REPORTED THAT THE PRODUCT IS SUBLICATING. THE PATIENT IS IN A LOT OF PAIN. THIS HAPPENS WHEN SHE SITS OR STANDS. THE DOCTOR CAN FILL IT AND IT MAKES A POPPING NOISE. SHE DOES POP IT BACK IN. THE PRODUCT WAS NOT RETURNED TO J&J MEDTECH ORTHOPAEDICS, HOWEVER PHOTOS WERE PROVIDED FOR REVIEW. (B)(4) STICKER SHEET AD 18 FEB 2025, (B)(4) STICKER SHEET AD 18 FEB 2025 - 1, (B)(4) STICKER SHEET AD 18 FEB 2025 - 2, (B)(4) STICKER SHEET AD 18 FEB 2025 - 3, (B)(4) STICKER SHEET AD 18 FEB 2025 - 4, (B)(4) STICKER SHEET AD 18 FEB 2025 - 5, (B)(4) STICKER SHEET AD 18 FEB 2025 - 6. THE PHOTOGRAPHS ATTACHED WERE REVIEWED, HOWEVER THEY DO NOT REPRESENT THE REPORTED COMPLAINT. THEREFORE, THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT DUE TO THE INSUFFICIENT EVIDENCE PROVIDED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT CODE: 198725413 LOT NUMBER: JC7592, AND NO NON-CONFORMANCES OR MANUFACTURING IRREGULARITIES WERE IDENTIFIED. AS THE DEVICE WAS NOT RETURNED, AN AS-RECEIVED CONDITION COULD NOT BE ASSESSED, AND A DIMENSIONAL INSPECTION AND DOCUMENT/SPECIFICATION REVIEW WERE NOT COMPLETED. THE OVERALL COMPLAINT WAS NOT CONFIRMED AS THE PHOTOGRAPHS PROVIDED ARE NOT REPRESENTATIVE OF THE REPORTED COMPLAINT. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION. AS PART OF J&J MEDTECH ORTHOPAEDICS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT CODE: 198725413 LOT NUMBER: JC7592, AND NO NON-CONFORMANCES OR MANUFACTURING IRREGULARITIES WERE IDENTIFIED. DEVICE HISTORY REVIEW: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT CODE: 198725413 LOT NUMBER: JC7592, AND NO NON-CONFORMANCES OR MANUFACTURING IRREGULARITIES WERE IDENTIFIED.
PRODUCT COMPLAINT #(B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES HAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H11 ADDITIONAL NARRATIVE: ADDED: B5, D10 (CONCOMITANT), H6 (HEALTH EFFECT - IMPACT CODE). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.
PRODUCT COMPLAINT #: (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H11 ADDITIONAL NARRATIVE: ADDED: B5 IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.
PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: IT WAS REPORTED THAT THE PRODUCT IS SUBLICATING. THE PATIENT IS IN A LOT OF PAIN. THIS HAPPENS WHEN SHE SITS OR STANDS. THE DOCTOR CAN FILL IT AND IT MAKES A POPPING NOISE. SHE DOES POP IT BACK IN. THE PRODUCT WAS NOT RETURNED TO J&J MEDTECH ORTHOPAEDICS, HOWEVER PHOTOS WERE PROVIDED FOR REVIEW. (B)(4) STICKER SHEET AD 18 FEB 2025, (B)(4) STICKER SHEET AD 18 FEB 2025 - 1, (B)(4) STICKER SHEET AD 18 FEB 2025 - 2, (B)(4) STICKER SHEET AD 18 FEB 2025 - 3, (B)(4) STICKER SHEET AD 18 FEB 2025 - 4, (B)(4) STICKER SHEET AD 18 FEB 2025 - 5, (B)(4) STICKER SHEET AD 18 FEB 2025 - 6. THE PHOTOGRAPHS ATTACHED WERE REVIEWED, HOWEVER THEY DO NOT REPRESENT THE REPORTED COMPLAINT. THEREFORE, THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT DUE TO THE INSUFFICIENT EVIDENCE PROVIDED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT CODE: 198725413 LOT NUMBER: JC7592, AND NO NON-CONFORMANCES OR MANUFACTURING IRREGULARITIES WERE IDENTIFIED. AS THE DEVICE WAS NOT RETURNED, AN AS-RECEIVED CONDITION COULD NOT BE ASSESSED, AND A DIMENSIONAL INSPECTION AND DOCUMENT/SPECIFICATION REVIEW WERE NOT COMPLETED. THE OVERALL COMPLAINT WAS NOT CONFIRMED AS THE PHOTOGRAPHS PROVIDED ARE NOT REPRESENTATIVE OF THE REPORTED COMPLAINT. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION. AS PART OF J&J MEDTECH ORTHOPAEDICS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT CODE: 198725413 LOT NUMBER: JC7592, AND NO NON-CONFORMANCES OR MANUFACTURING IRREGULARITIES WERE IDENTIFIED. DEVICE HISTORY REVIEW: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT CODE: 198725413 LOT NUMBER: JC7592, AND NO NON-CONFORMANCES OR MANUFACTURING IRREGULARITIES WERE IDENTIFIED.
IT WAS REPORTED THAT THE PRODUCT IS SUBLICATING. THE PATIENT IS IN A LOT OF PAIN. THIS HAPPENS WHEN SHE SITS OR STANDS. THE DOCTOR CAN FILL IT AND IT MAKES A POPPING NOISE. SHE DOES POP IT BACK IN. PATIENT SHATTERED THE LOWER FEMUR ON HER LEFT LEG AT THE POINT WHERE IT MET HER ARTIFICIAL KNEE. SINCE THAT TIME, THE PATIENT HAS HAD MULTIPLE "PARTIAL DISLOCATIONS" WHERE THE KNEE FEELS LIKE IT POPS OUT AND THEN HAS TO BE PUSHED BACK INTO PLACE. AFFECTED SIDE: LEFT. DOI: (B)(6) 2022.
ADDITIONAL INFORMATION RECEIVED: MY MOM IS STILL HAVING TERRIBLE PAIN WHEN SHE BENDS/STRAIGHTENS HER KNEE. THEY TRIED A NERVE BLOCK BUT IT SEEMS IT¿¿S ACTUALLY THE KNEE JOINT THAT IS POPPING IN AND OUT (RIGHT TO LEFT) WHEN SHE CHANGES POSITION. ARE THERE ANY REPORTS OF THIS KNEE (SEE PARTS BELOW) OF HAVING OVER-FLEXING SIDE TO SIDE? SOMETHING HAS TO BE ABLE TO HELP HER MANAGE THIS PAIN. WE HAVE TRIED VARIOUS BRACES THAT TRY TO HOLD THE KNEE FROM POPPING OUT BUT HAVEN'T FOUND THE RIGHT ONE YET. NO FURTHER INFORMATION IS AVAILABLE.
ADDITIONAL INFORMATION WAS RECEIVED AND STATED ON A CALL LAST (B)(6) 2025, THE PATIENT HAD A ROD PLACED AND A REVISION OF THE KNEE WAS PERFORMED DUE TO LOWER FEMUR FRACTURE (SHATTERED) ON (B)(6) 2025. SINCE THAT TIME, THE PATIENT HAS HAD MULTIPLE "PARTIAL DISLOCATIONS" WHERE THE KNEE FEELS LIKE IT POPS OUT AND THEN HAS TO BE PUSHED BACK INTO PLACE. THE PATIENT HAS BEEN EXPERIENCING SEVERE PAIN DURING THOSE EPISODES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 403894 | LPS CEMENTED STEM 13X125MM STR | LPS AND S-ROM : KNEE STEMS | JWH | DEPUY ORTHOPAEDICS INC US | JC7592 | 10603295079187 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |