PINN LNR CON +4 NEUT 28IDX50OD
Report
- Report Number
- 1818910-2016-30949
- Event Type
- Malfunction
- Date Received
- November 7, 2016
- Date of Event
- July 26, 2016
- Report Date
- November 7, 2019
- Manufacturer
- DEPUY ORTHOPAEDICS INC US
- Product Code
- KWZ
- PMA / PMN Number
- K043058
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- ATTORNEY
Narratives
PRODUCT COMPLAINT #: (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. 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 : INVESTIGATIVE UPDATE: 29 / OCT / 2021. X-RAY IMAGES HAVE BEEN PROVIDED FOR REVIEW. NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. X-RAY IMAGES HAVE BEEN PROVIDED FOR REVIEW. THE IMAGES DO DEPICT A DISLOCATION EVENT AS ALLEGED. REGRADING THE ACETABULAR LINER, NOTHING INDICATIVE OF A PRODUCT PROBLEM IS IDENTIFIED. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT : THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MATERIAL, MANUFACTURING, INSPECTION OR STERILE PROCESSING THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED.
PRODUCT COMPLAINT #: (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT.
MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED TO PERFORM AN EXCISIONAL IRRIGATION AND DEBRIDEMENT AS WELL AS AN EXTENDED TROCHANTERIC OSTEOTOMY OF THE HIP TO ADDRESS DISLOCATION, EXTENSIVE METALLOSIS AND DAMAGED TRUNNION OF THE FEMORAL COMPONENT.
AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED FOR LEFT HIP DISLOCATION, EXTENSIVE METALLOSIS, AND DAMAGE TO THE TRUNNION OF THE FEMORAL NECK SECONDARY TO METAL ON METAL ARTICULATION. OPERATIVE NOTES REPORTED THAT THERE WAS EXTENSIVE MELANOSIS. METALLOSIS WAS CONFIRMED AND DEBRIDE. IT WAS NOTED THAT THE POSTERIOR ASPECT OF THE LINER HAD COMPLETELY WORN AWAY TO THE METAL RETAINING RING. POSTERIOR ASPECT OF THE TRUNNION HAD SIGNIFICANT GOUGE WHERE IT APPEARS TO HAVE BEEN ARTICULATING WITH THE POSTERIOR RETAINING RING. A SIGNIFICANT ATTEMPT TO REMOVE THE STEM FROM THE SLEEVE, RESULTED IN FRACTURING THE METAPHYSEAL SLEEVE COMPONENT AND A PORTION OF THE INTERTROCHANTERIC BONE. DURING OSTEOTOMY THE FEMUR DID BREAK INTO MULTIPLE PIECES AS IT HAD COMPLETELY GROWN IN THE FLUTES IF THE STEM ON ALL SIDES.
NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE LOT SPECIFIC COMPLAINT DATABASE SEARCH, OR DEVICE HISTORY RECORD (DHR) REVIEW WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT CODE(S) WAS NOT PROVIDED. BASED ON PREVIOUS INVESTIGATIONS THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS THE PATIENT WAS REVISED ON (B)(6) 2016. THE PFS INDICATED THE PATIENT WAS REVISED FOR DISLOCATION AND A FRACTURED STEM. THE STEM HAS ALREADY BEEN REPORTED ON (B)(4). PART/LOT HASN'T BEEN PROVIDED AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 732606 | PINN LNR CON +4 NEUT 28IDX50OD | PINNACLE HIP SYSTEM : HIP CONSTRAINED ACETABULAR LINERS | KWZ | DEPUY ORTHOPAEDICS INC US | 538304 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Required Intervention |