SIGMA HP TROCHLEA SZ1 LT
Received Feb 9, 2022 · Event occurred Jan 28, 2022
Report 1818910-2022-02569 · MDR key 13498070
Device
Generic name
Early Intervention : Knee Femoral
Manufacturer
Depuy Orthopaedics Inc UsModel number
1024-03-100Catalog number
102403100
Lot number
192158
Product problems
- Loss of or Failure to Bond
- Device Dislodged or Dislocated
- Loss of or Failure to Bond
- Device Dislodged or Dislocated
Patient
Female
- Pain
- Joint Dislocation
- Pain
- Joint Dislocation
Narrative
Additional Manufacturer Narrative
PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
Description of Event or Problem
PATIENT UNDERWENT PRIMARY PATELLA FEMORAL JOINT REPLACEMENT IN (B)(6) 2015. (B)(6) HOSPITAL. PATIENT HAS COMPLAINED THAT THIS PF JOINT HAS NEVER FELT GOOD AND HAS BEEN PAINFUL SINCE TIME INDEX SURGERY. A DECISION WAS MADE TO REVISE THE PF JOINT TO A TOTAL KNEE REPLACEMENT. ON OPENING THE KNEE, THE FEMORAL COMPONENT WAS FOUND TO BE LOOSE. PROGRESSION ON DISEASE WAS ALSO FOUND IN THE OTHER CONDYLES. THE FEMORAL COMPONENT AS WELL AS THE INSERT PATELLA COMPONENT WAS REMOVED AND A TOTAL JOINT I PLANTED. ((B)(6) HOSPITAL, (B)(6) 2022). DEPUY CEMENT WAS NOT UTILISED. THE FEMORAL COMPONENT WAS LOOSE AT THE CEMENT BONE INTERFACE WITH THE COMPONENT COMING LOOSE WITH THE CEMENT STILL ADHERED TO THE UNDERSIDE. DOI: (B)(6) 2015; DOR: (B)(6) 2022; UNKNOWN KNEE.
Additional Manufacturer Narrative
PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
Description of Event or Problem
PATIENT UNDERWENT PRIMARY PATELLA FEMORAL JOINT REPLACEMENT IN (B)(6) 2015. (B)(6) HOSPITAL. PATIENT HAS COMPLAINED THAT THIS PF JOINT HAS NEVER FELT GOOD AND HAS BEEN PAINFUL SINCE TIME INDEX SURGERY. A DECISION WAS MADE TO REVISE THE PF JOINT TO A TOTAL KNEE REPLACEMENT. ON OPENING THE KNEE, THE FEMORAL COMPONENT WAS FOUND TO BE LOOSE. PROGRESSION ON DISEASE WAS ALSO FOUND IN THE OTHER CONDYLES. THE FEMORAL COMPONENT AS WELL AS THE INSERT PATELLA COMPONENT WAS REMOVED AND A TOTAL JOINT I PLANTED. ((B)(6) HOSPITAL, (B)(6) 2022). DEPUY CEMENT WAS NOT UTILISED. THE FEMORAL COMPONENT WAS LOOSE AT THE CEMENT BONE INTERFACE WITH THE COMPONENT COMING LOOSE WITH THE CEMENT STILL ADHERED TO THE UNDERSIDE. DOI: (B)(6) 2015; DOR: (B)(6) 2022; UNKNOWN KNEE.
Additional Manufacturer Narrative
PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS COMPLAINT WAS RECEIVED FOR INVESTIGATION. THE PHOTO INVESTIGATION CANNOT CONFIRM THE REPORTED ALLEGATION. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT: THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED.