BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 32/0, TAPER 12/14
Report
- Report Number
- 0009613350-2023-00359
- Event Type
- Injury
- Date Received
- July 5, 2023
- Date of Event
- October 31, 2022
- Report Date
- July 18, 2023
- Manufacturer
- ZIMMER SWITZERLAND MANUFACTURING GMBH
- Product Code
- LZO
- PMA / PMN Number
- K192416
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. THE PATIENT IS FEMALE AND BORN IN 1960, 167 CM AND 69 KG (BMI 25.3). AN INITIAL RIGHT THA WAS PERFORMED A YEAR AGO WITH NO COMPLICATIONS NOTED. APPROXIMATELY ONE MONTH AFTERWARDS, THE PATIENT REPORTED MILD PAIN AND WAS PRESCRIBED AN OTC MEDICATION. TWO MONTHS AFTER THE INITIAL THA, THE PATIENT SUFFERED OF HIP DISLOCATION: NO INFORMATION WERE PROVIDED ON THE TYPE OF INTERVENTION TO REDUCE THE DISLOCATION, BUT A ABDUCTION BRACE WAS ADVISED FOR 6 WEEKS. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A RADIOLOGIST. TWO VIEWS OF THE RIGHT HIP LABELED IMMEDIATE POSTOP DEMONSTRATE A RIGHT TOTAL HIP ARTHROPLASTY WITH SCREW FIXATION OF THE ACETABULAR CUP. NO RADIOLUCENCY. THREE VIEWS OF THE RIGHT HIP LABELED TWO WEEKS POSTOP DEMONSTRATE A RIGHT TOTAL HIP ARTHROPLASTY WITH DEVELOPING RADIOLUCENCY ALONG THE ACETABULAR CUP. THREE VIEWS OF THE RIGHT HIP LABELED SIX WEEKS POSTOP DEMONSTRATE PERSISTENT RADIOLUCENCY ALONG THE ACETABULAR CUP OF A RIGHT TOTAL HIP ARTHROPLASTY. OVERALL FIT AND ALIGNMENT OF THE IMPLANTS IS APPROPRIATE. NORMAL BONE MINERALIZATION. RADIOLUCENCY DEVELOPS ALONG THE ACETABULAR CUP SUGGESTING POSSIBLE LOOSENING. RADIOLUCENCY DEVELOPS ALONG THE ACETABULAR CUP AT TWO-WEEK SUGGESTING POSSIBLE LOOSENING BUT REMAINS STABLE AT SIX WEEKS. NO DEFINITE SIGNS OF POSITION CHANGE OF THE ACETABULAR CUP. WITH THE AVAILABLE INFORMATION A DEFINITIVE ROOT CAUSE CANNOT BE ESTABLISHED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
(B)(4). D10 - MEDICAL DEVICES: G7 LONGEVITY HIGH WALL 32MM E; ITEM# 20123205; LOT# 64615803; G7 OSSEOTI MULTIHOLE 52MM E; ITEM# 110010264; 65028847; BONE SCR 6.5X25 SELF-TAP; ITEM# 00625006525; LOT# J7241811; BONE SCR 6.5X30 SELF-TAP; ITEM# 00625006530; LOT# J7250396; FEMORAL STEM PRESS-FIT COLLARLESS 12/14 NECK TAPER STANDARD BODY EXTENDED NECK OFFSET SIZE 13 138 MM STEM LENGTH CEMENTLESS; ITEM# 00786401320; LOT# 64999789. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
IT WAS REPORTED A PATIENT HAD AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, APPROXIMATELY TWO MONTHS LATER, THE HIP DISLOCATED REQUIRING A HIP ABDUCTION BRACE TO BE WORN FOR SIX WEEKS. TO DATE, NO REVISION HAS BEEN SCHEDULED AND ALL IMPLANTS REMAIN IN PLACE. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 885023 | BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 32/0, TAPER 12/14 | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS | LZO | ZIMMER SWITZERLAND MANUFACTURING GMBH | 00-8775-032-02 | 3102189 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention| H |