M2A-38 CUP NON FLARED SZ 56MM
Report
- Report Number
- 0001825034-2023-00342
- Event Type
- Injury
- Date Received
- February 16, 2023
- Date of Event
- January 25, 2023
- Report Date
- April 13, 2023
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- KWA
- PMA / PMN Number
- K011110
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.
(B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM NUMBER: X11-180313 ITEM NAME: BI-METRIC/X POR NC LAT 13X145 LOT NUMBER: 386650; ITEM NUMBER: 11-173663 ITEM NAME: M2A 38MM MOD HD +3MM NK LOT NUMBER: 780870; ITEM NUMBER: 31-323230 ITEM NAME: 3.2MMX30MM RNGLC+ ACET DRL BIT LOT NUMBER:355010; ITEM NUMBER: 00-510-400-00 ITEM NAME: EXODUS HIP STEM REMOVAL BLADES LOT NUMBER: 21021; ITEM NUMBER: 430060 ITEM NAME: RADIAL OSTEOTOME 6MM LOT NUMBER: 541312; ITEM NUMBER: 11-300818 ITEM NAME: ARCOS 18X150MM SPL TPR DIST LOT NUMBER: 381820; ITEM NUMBER: 11-301312 ITEM NAME: ARCOS CON SZ B HI 60MM LOT NUMBER: 838120; ITEM NUMBER: 11-302101 ITEM NAME: ARCOS TROCH CLAW LARGE 100MM LOT NUMBER: 506530; ITEM NUMBER: 11-302138 ITEM NAME: ARCOS LATERAL TROCH BOLT 38MM LOT NUMBER:240720 ; ITEM NUMBER: 650-1055 ITEM NAME: CER BIOLOXD OPTION HD 28MM LOT NUMBER: 3130999 ; ITEM NUMBER: 650-1064 ITEM NAME: CER OPTION TYPE 1 TPR SLEVE -6 LOT NUMBER: 3100122; ITEM NUMBER: 110010268 ITEM NAME: G7 OSSEOTI MULTIHOLE 60MM G LOT NUMBER: 6833750; ITEM NUMBER: 110024465 ITEM NAME: G7 DUAL MOBILITY LINER 46MM G LOT NUMBER: 358140; ITEM NUMBER: 110031013 ITEM NAME: VIVACIT-E DM BEARING 28X46MM LOT NUMBER: 65254751 ; ITEM NUMBER: 00-6250-065-40 ITEM NAME: BONE SCREW 6.5X40 SELFTAP LOT NUMBER: J7250390; ITEM NUMBER: 00-6250-065-25 ITEM NAME: BONE SCREW 6.5X25 SELFTAP LOT NUMBER: J7280773; ITEM NUMBER: 00-6250-065-30 ITEM NAME: BONE SCREW 6.5X30 SELFTAP LOT NUMBER: 65514448; ITEM NUMBER: 65514448 ITEM NAME: BONE SCREW 6.5X30 SELFTAP LOT NUMBER: 65013422 ; ITEM NUMBER: 00-2232-004-18 ITEM NAME: CABLE-READY CABLE ASSY CERCLAGE COCR 1.8MM X 635MM LOT NUMBER: 65459439; ITEM NUMBER: 00-2232-004-18 ITEM NAME: CABLE-READY CABLE ASSY CERCLAGE COCR 1.8MM X 635MM LOT NUMBER: 65632345; ITEM NUMBER:00-2232-004-18 ITEM NAME: CABLE-READY CABLE ASSY CERCLAGE COCR 1.8MM X 635MM LOT NUMBER: 65656496. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2023-00339, 0001825034-2023-00341. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT¿S LOCATION IS NOT KNOWN; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, AS SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.
UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY DUE TO A DISLOCATED HIP AND DISASSOCIATED FEMORAL HEAD FROM STEM. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 608817 | M2A-38 CUP NON FLARED SZ 56MM | PROSTHETIC, HIP | KWA | ZIMMER BIOMET, INC. | N/A | 949000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Male | Required Intervention| H | PLEASE SEE H10 |