COMPREHENSIVE REVERE SHOULDER FIXED LOCKING SCREW 3.5MM HEX 4.75 X 20MM
Report
- Report Number
- 0001825034-2016-03745
- Event Type
- Injury
- Date Received
- September 21, 2016
- Date of Event
- November 28, 2016
- Report Date
- May 31, 2018
- Manufacturer
- BIOMET ORTHOPEDICS
- Product Code
- KWS
- PMA / PMN Number
- PK132239
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
REPORTED EVENT WAS CONFIRMED BY REVIEW OF THE PROVIDED OP NOTES AND X-RAYS. PER THE REVISION OPERATIVE NOTES, THE PATIENT HAD MECHANICAL FAILURE WITH SEVERE BONE LOSS. THE GLENOSPHERE AND BASEPLATE WERE LOOSE WITH A LARGE DEFECT. PER THE CT SCAN RESULTS, THERE WAS SUPERIOR DISPLACEMENT OF THE SCAPULAR COMPONENT WITH ASSOCIATED 18MM BONY FRAGMENT SUGGESTIVE OF A MODERATELY DISPLACED FRACTURE FROM THE ANTERIOR ASPECT OF THE GLENOID AND SCAPULAR SPINE. THERE APPEARS TO BE A NONDISPLACED FRACTURE THROUGH THE BASE OF THE CORACOID PROCESS AS WELL. PER THE X-RAY REVIEW, "COMPLAINT SUGGESTS LOOSENING OF ALL THE SCREWS. THIS COULD BE IDENTIFIED RADIOGRAPHICALLY AS PERIPROSTHETIC LUCENCIES SURROUNDING THE SCREWS. THE ONLY IMAGES THAT SHOW THE SCREWS ARE 1, 2, AND 5. NONE OF THESE IMAGES REVEAL THIS TO BE CONFIRMED. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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.
THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. (B)(4). CONCOMITANT MEDICAL PRODUCTS - BIOMET COMPREHENSIVE HUMERAL TRAY WITH LOCKING RING CATALOG#: 115370 LOT #:910020, BIOMET COMPREHENSIVE MINI HUMERAL STEM CATALOG #113630 LOT#836390, BIOMET HUMERAL BEARING CATALOG # XL-115363 LOT#502530.
CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 3 STATES, "INTRAOPERATIVE BONE PERFORATION OR FRACTURE MAY OCCUR, PARTICULARLY IN THE PRESENCE OF POOR BONE STOCK CAUSED BY OSTEOPOROSIS, BONE DEFECTS FROM PREVIOUS SURGERY, BONE RESORPTION, OR WHILE INSERTING THE DEVICE." NUMBER 4 STATES, "LOOSENING OR MIGRATION OF THE IMPLANTS CAN OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION AND/OR EXCESSIVE ACTIVITY." NUMBER 13 STATES, "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 1 OF 3 MDR'S FILED FOR THE SAME PATIENT (REFERENCE 1825034-2016-03745 / 03746 / 03747).
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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.
IT WAS REPORTED PATIENT UNDERWENT A RIGHT SHOULDER REVISION PROCEDURE APPROXIMATELY FIVE MONTHS POST-IMPLANTATION DUE TO ALLEGED PAIN, SWELLING, LOOSE SCREWS, AND BONE FRACTURES AND WEAR. PRIOR TO THE REVISION, THE SURGEON ALSO ALLEGEDLY NOTED THAT THE INITIAL COMPONENTS WERE MALPOSITIONED. THE STEM REMAINED IMPLANTED AND ALL OTHER COMPONENTS WERE REMOVED AND REPLACED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.
PATIENT REPORTED A RIGHT SHOULDER REVISION PROCEDURE MAY OCCUR APPROXIMATELY THREE MONTHS POST-IMPLANTATION DUE TO ALLEGED PAIN, SWELLING, LOOSE SCREWS, AND BONE FRACTURE; HOWEVER, NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED REPORTED MALPOSITIONING OF COMPONENTS DURING THE INITIAL PROCEDURE MAY HAVE CONTRIBUTED TO INDICATED REVISION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 618062 | COMPREHENSIVE REVERE SHOULDER FIXED LOCKING SCREW 3.5MM HEX 4.75 X 20MM | PROSTHESIS, SHOULDER, SCREW | KWS | BIOMET ORTHOPEDICS | N/A | 061420 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Hospitalization| R |