SULOX, HEAD, L, 32/+3.5, TAPER 12/14
Report
- Report Number
- 0009613350-2023-00494
- Event Type
- Injury
- Date Received
- August 29, 2023
- Date of Event
- July 28, 2023
- Report Date
- December 7, 2023
- Manufacturer
- ZIMMER SWITZERLAND MANUFACTURING GMBH
- Product Code
- KWA
- UDI-DI
- 00889024416994
- PMA / PMN Number
- N/A
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). D10 ¿ UNKNOWN PE INLAY; ITEM#: UNKNOWN; LOT#: UNKNOWN. G2 ¿ FOREIGN ¿ GERMANY. INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: A2, A4, B4, B5, B7, D4, D10, G3, G6, H1, H2, H3, H4, H6, H10 D10 - ORIGINAL M.E. MALLER, STEM, PT-S30, STRAIGHT, LATERAL, CEMENTED, 12.5, TAPER 12/14 ITEM#350039125 LOT#3021608 INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: A1; D6A; G3; H2; H3; H6. CORRECTED: B3. MEDICAL RECORDS WERE PROVIDED AND REVIEWED. THE PATIENT UNDERWENT AN INITIAL RIGHT THA DUE TO COXARTHROSIS. SUBSEQUENTLY, THE PATIENT UNDERWENT X-RAYS EXAMINATION DUE TO HIP PAIN, THE RESULTS OF WHICH SHOWS A FRACTURE OF THE HEAD; THEREFORE, PATIENT UNDERWENT A REVISION SURGERY. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A RADIOLOGIST. AP PELVIS AND SINGLE VIEW OF THE RIGHT HIP BEFORE INITIAL IMPLANTATION DEMONSTRATE SEVERE RIGHT HIP DEGENERATE CHANGE WITH BONE ON-BONE APPEARANCE AND FLATTENING OF THE FEMORAL HEAD ALONG WITH SUBCHONDRAL SCLEROSIS, CYST FORMATION AND OSTEOPHYTE FORMATION. AP PELVIS AND SINGLE VIEW OF THE RIGHT HIP AFTER INITIAL IMPLANTATION DEMONSTRATE A RIGHT TOTAL HIP ARTHROPLASTY WITH CEMENT FIXATION OF THE ACETABULAR CUP. NO RADIOLUCENCY. NO FRACTURE. SIZING OF THE IMPLANT IS APPROPRIATE. AP PELVIS AND SINGLE VIEW OF THE RIGHT HIP BEFORE REVISION SURGERY DEMONSTRATE FRACTURE OF THE CERAMIC HEAD WITH MULTIPLE HYPERDENSE FRAGMENT SEEN WITHIN THE JOINT SPACE. THE SULOX HEAD AND THE XONIT X-PE INSERT WERE RETURNED FOR INVESTIGATION. THE SULOX HEAD IS FRACTURED INTO SEVERAL PIECES. ON THE FRACTURE SURFACES OF THE HEAD IT IS POSSIBLE TO SEE METAL TRANSFER PATTERNS, CHIPPING AND WEAR, MOST LIKELY CAUSED BY THE STEM AND THE CERAMIC FRAGMENTS AFTER THE FRACTURE OCCURRED. ON THE TAPER OF THE HEAD, IT IS ALSO POSSIBLE TO SEE SOME METAL TRANSFER; HOWEVER, NO CONSISTENT SEATING PATTERN CAN BE RECOGNIZED. THE OUTER SURFACE OF THE INSERT SHOWS SOME SCRATCHES, DENTS AS WELL AS SOME MATERIAL PEELING OFF. ON THE ARTICULATING SURFACE OF THE INSERT EXTENSIVE DAMAGES IN THE FORM OF ABRASION AND SCRATCHES CAN BE SEEN. ADDITIONALLY, MATERIAL WEAR AND DEFORMATION IN THE FORM OF A DEEP DENT CAN BE SEEN, MOST LIKELY DUE TO THE CONTACT OF THE STEM TAPER WITH THE INSERT AFTER THE HEAD FRACTURE. THE RIM OF THE INSERT SHOWS SOME SCRATCHES. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. 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 THAT THE PATIENT UNDERWENT A REVISION OF A CERAMIC HEAD AND LINER DUE TO SUDDEN PAIN, APPROXIMATELY THREE (3) YEARS AFTER INITIAL SURGERY. X-RAYS CONFIRMED CERAMIC HEAD FRACTURE. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2101873 | SULOX, HEAD, L, 32/+3.5, TAPER 12/14 | HIP PROTHESIS | KWA | ZIMMER SWITZERLAND MANUFACTURING GMBH | N/A | 3032324 | 00889024416994 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 90 YR | Male | Hospitalization| R |