M2A-MAGNUM MOD HD SZ 44MM 44MM
Report
- Report Number
- 0001825034-2024-01443
- Event Type
- Injury
- Date Received
- June 3, 2024
- Date of Event
- October 5, 2023
- Report Date
- August 28, 2025
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- LPH
- PMA / PMN Number
- K042037
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: UPDATED: H6 PROPOSED COMPONENT CODE: MECHANICAL (G04)- HEAD. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: AFTER UNDERGOING AN INITIAL RIGHT THA , THE PATIENT BEGAN EXPERIENCING PAIN AND DIFFICULTY AMBULATING WITH ELEVATED METAL IONS AND PSEUDOTUMOR. DURING THE REVISION, METALLOSIS WAS IDENTIFIED WITHIN THE JOINT WITH THE PSEUDOTUMOR. THE TRUNNION WAS CLEANED AND THE STEM REMAINED. THE HEAD AND ADAPTER WERE EXPLANTED AND REPLACED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THIS COMPLAINT WAS CONFIRMED BASED ON THE PROVIDED MEDICAL RECORDS. 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.
(B)(4). D10: US157850, ITEM NAME: M2A-MAGNUM PF CUP 50ODX44ID, LOT #: 395540. 11-104113, ITEM NAME: MLRY-HD POR FMRL 13X170MM, LOT #: 042090. 139252, ITEM NAME: M2A-MAGNUM 42- 50MM TPR INSRT-6 0/-6MMT1, LOT #: 133250. 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, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D9, G3, G6, H2, H3, H6, H11. D4 - UDI IS NOT APPLICABLE; THE DEVICE WAS MANUFACTURED PRIOR TO DI PUBLISH DATE. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED THE MOD HEAD HAS DARK METALLIC LIKE MARKS ON THE O.D. AND TOP FLAT SURFACES. THERE ARE MULTIPLE INDENTATIONS ON THE TOP FLAT SURFACE. SCRATCHES ARE ALSO PRESENT ON THE O.D. AND TOP FLAT SURFACES. A CONSENSUS MODIFIED GOLDBERG SCORE OF 2 WAS DETERMINED FOR THE TAPER. A SCORE OF 2 CORRESPONDS TO FRETTING ON >10% OF THE SURFACE AND/OR CORROSION DAMAGE TO ONE OR MORE SMALL AREAS. THE ROOT CAUSE IS UNCHANGED. THIS COMPLAINT WAS CONFIRMED BASED ON THE PREVIOUSLY REPORTED MEDICAL RECORDS. IF ANY FURTHER INFORMATION IS FOUND THAT WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE 10 YEARS AND 9 MONTHS POST IMPLANTATION DUE TO PAIN, DIFFICULTY AMBULATING, ELEVATED METAL ION LEVELS AND A PSEUDOTUMOR. DURING THE REVISION SIGNIFICANT METALLOSIS WAS NOTED. THE STEM WAS FOUND TO HAVE SIGNIFICANT INGROWTH THEREFORE NOT EXPLANTED, THE HEAD WAS REVISED WITHOUT COMPLICATIONS. THERE IS NO ADDITIONAL INFORMATION AT THE TIME OF THIS REPORT.
THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1939768 | M2A-MAGNUM MOD HD SZ 44MM 44MM | PROSTHETIC, HIP | LPH | ZIMMER BIOMET, INC. | N/A | 297020 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Female | Hospitalization| R | PLEASE SEE H11. |