MOD ARTHRO NL 3CM DIASL CNCTR
Report
- Report Number
- 0001825034-2019-02183
- Event Type
- Injury
- Date Received
- May 15, 2019
- Date of Event
- April 13, 2019
- Report Date
- January 31, 2020
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- HSB
- PMA / PMN Number
- K042409
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV, US
- Reporter Occupation
- PHYSICIAN
Narratives
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPDATED: B4, G4, G7, H2, H3, H6, AND H10. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL INSPECTION CONFIRMED THAT THE DIAPHYSEAL CONNECTOR FRACTURED ON THE SHAFT. FURTHER EVALUATION IDENTIFIED THAT THERE WAS SOME ADDITIONAL DAMAGE SEEN PROBABLY THAT OCCURRED WHEN THE CONSTRUCT WAS REMOVED. IT LOOKS LIKE A SAW OR MIDAS REX WAS USED TO SLICE THE SIDE OF THE DIAPHYSEAL CONNECTOR AND IT LOOKS LIKE THE DIAPHYSEAL ADAPTOR BROKE (OR WAS CUT TO GET THE CONSTRUCT APART) BETWEEN THE ADAPTER BODY AND THE CLAMSHELL. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. 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.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
(B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-02184, 0001825034-2019-02185, AND 0001825034-2019-02186. LOT NUMBER IS EITHER 580090 OR 181570. MOD ARTHRO NL 3CM DIASL CNCTR CATALOG#: CP260607; LOT 580090: MANUFACTURE DATE: FEB 13, 2014, EXPIRATION DATE: 28-FEB-2024; LOT 181570: MANUFACTURE DATE: JUL 19, 2014, EXPIRATION DATE: 31-JUL-2024. CONCOMITANT MEDICAL PRODUCTS: MEDICAL DEVICES: MOD ARTHRO 0 DEG LCK COLLAR CATALOG#: CP260600 LOT#: 341290, OSS SEGMENTAL STACKING ADAPTER CATALOG# 150483 LOT#: 302180, UNKNOWN SCREW CATALOG#: NI LOT#: NI; CPS LG SPDL WITH PINS 800LBF CATALOG#: 178358 LOT#: 502600, CPS LG SPDL WITH PINS 800LBF CATALOG#: 178404 LOT#: 213070, CPS TRANSVERSE PIN 6PK 32MM CATALOG#: 178527 LOT#: 134880, CPS CENTERING SLEEVE 18MM CATALOG#: 178540 LOT#: 131070, CPS NUT CO-CR-MO ALLOY CATALOG#: 178512 LOT#: 498690, CPS ANCHOR PLUG 10MM CATALOG#: 178400 LOT#: 182490, CPS SM SPDL WITH PINS 800LBF CATALOG#: 178355 LOT#: 717020, CPS/OSS 5CM TPR ADAPT W/OSS SC CATALOG#: 178711 LOT#: 433100, CPS NUT CO-CR-MO ALLOY CATALOG#: 178512 LOT#: 222820, CPS TRANSVERSE PIN 6PK 32MM CATALOG#: 178527 LOT#: 742300, CPS CENTERING SLEEVE 15MM CATALOG#: 178537 LOT#: 935290, CPS/OSS 5CM TPR ADAPT W/OSS SC CATALOG#: 178711 LOT#: 250750, MOD ARTHRO NL 3CM DIASL CNCTR CATALOG#: CP260607 LOT#: 580090 OR 181570, OSS 4CM DIAPHYSEAL SEGMENT CATALOG#: 150482 LOT#: 801580, OSS SEGMENTAL STACKING ADAPTER CATALOG#: 150483 LOT#: 580530, MOD ARTHRO 0 DEG LCK COLLAR CATALOG#: CP260600 LOT#: 491090. PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
IT WAS REPORTED THAT PATIENT UNDERWENT INITIAL KNEE ARTHROPLASTY. SUBSEQUENTLY, UNDERWENT A REVISION DUE THE IMPLANT FRACTURED WHILE WALKING FOUR (4) YEAR FIVE (5) MONTHS POST PRIMARY IMPLANTATION. PATIENT WAS WALKING FIVE MILE PER DAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 405081 | MOD ARTHRO NL 3CM DIASL CNCTR | PLATE, FIXATION | HSB | ZIMMER BIOMET, INC. | N/A | 087210 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR | Hospitalization| R | SEE H10 |