KINECTIV MODULAR NECK D
Report
- Report Number
- 0001822565-2023-00260
- Event Type
- Injury
- Date Received
- January 31, 2023
- Date of Event
- October 8, 2018
- Report Date
- July 11, 2023
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- LPH
- PMA / PMN Number
- K182678
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE {UPDATE/CORRECTED} UPDATED: G3; H2; H3; H6 NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: BILATERAL TOTAL HIP ARTHROPLASTIES WITHOUT EVIDENCE FOR HARDWARE FAILURE OR LOOSENING. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: AN INITIAL LEFT THA WAS PERFORMED THAT WAS SUBSEQUENTLY REVISED APPROXIMATELY ONE (1) YEAR LATER DUE TO PAIN AND HEMATOMA FROM AN UNKNOWN INJURY TO THE LEFT LEG. DURING THE REVISION, METALLOSIS AND SCARING WAS IDENTIFIED AROUND THE TROCHANTER WHERE THE WIRES WERE PLACED. THE CABLES WERE REMOVED AS WELL AS THE HEAD, LINER, AND NECK THAT WERE EXCHANGED WITH NO COMPLICATIONS NOTED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED FOR ALL ISSUES REPORTED BESIDES THE HEMATOMA. NO PROBLEM WAS FOUND WITH THE DEVICES REGARDING THE HEMATOMA, AS REVIEW BY A HCP DETERMINED IT WAS PROCEDURE RELATED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
(B)(4). CONCOMITANT MEDICAL DEVICES: CAT# 00-2232-004-18 LOT# 63674177 CABLE READY GTR COCR CABLE, CAT#00-2232-004-18 LOT# 63716290 CABLE READY GTR COCR CABLE, CAT# 00-6202-058-22 LOT# 63365727 TM ACET SHELL 58MM CLUSTER, CAT# 00-7713-013-00 LOT# 63675172 M/L TPR KINECTIV STEM SZ 13.5. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565 - 2023 - 00172, 0002648920 - 2023 - 00007. THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS ITS LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE {UPDATE/CORRECTED} UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT SHOULD BE VOIDED.
NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.
IT WAS REPORTED THE PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY THE PATIENT NOTED THEY WERE REVISED APPROXIMATELY ONE (1) YEAR LATER DUE TO WORN POLY. MEDICAL RECORDS SHOW REVISION DUE TO PAIN AND HEMATOMA FROM AN UNKNOWN INJURY TO LEFT LEG. DURING THE REVISION, THE SURGEON NOTED METALLOSIS, SCARRING, AND LOCAL TISSUE REACTION. THE HEAD, NECK, AND LINER WERE EXCHANGED, THE CERCLAGE WIRES WERE REMOVED AND IRRIGATION AND DEBRIDEMENT TO HEMATOMA WITHOUT COMPLICATIONS. SUBSEQUENTLY AN IRRIGATION AND DEBRIDEMENT WAS PERFORMED APPROXIMATELY SEVEN (7) MONTHS AFTER REVISION DUE TO RECURRENT HEMATOMA WITH THREE (3) PREVIOUS ASPIRATIONS WITH NEGATIVE CULTURES. THE LARGE HEMATOMA WAS EXCISED WITH DRAIN PLACED WITHOUT COMPLICATIONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2105639 | KINECTIV MODULAR NECK D | PROSTHESIS, HIP | LPH | ZIMMER BIOMET, INC. | N/A | 61632186 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Hospitalization| R |