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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM PF CUP 52ODX46ID; PROSTHESIS, HIP

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ZIMMER BIOMET, INC. M2A-MAGNUM PF CUP 52ODX46ID; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problems Adhesion(s) (1695); Pain (1994); Local Reaction (2035); Scar Tissue (2060); Osteopenia/ Osteoporosis (2651)
Event Date 12/02/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).Concomitant medical devices: biomet head, cat#: 157446, lot#: 739140; biomet stem, cat#: 103204, lot#: 103204; biomet taper adapter, cat#: 139252, lot#: 974030.The device will not be returned for analysis, as the device location is unknown; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-01906.
 
Event Description
It was reported the patient underwent total hip arthroplasty approximately 12 years ago.The patient was revised last year due to pain.During the procedure it was noted the patient¿s implant had loosened, there was presence of scar tissue, and metal staining.Attempts have been made and additional information on the reported event is unavailable at this time.
 
Event Description
No further event information available at the time of this report.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The product was evaluated through manufacturing review and the reported event was confirmed through review of medical records.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information 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.
 
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Brand Name
M2A-MAGNUM PF CUP 52ODX46ID
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key10064968
MDR Text Key193624272
Report Number0001825034-2020-01905
Device Sequence Number1
Product Code LPH
Combination Product (y/n)N
PMA/PMN Number
K101336
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Type of Report Initial,Followup
Report Date 07/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/01/2018
Device Model NumberN/A
Device Catalogue NumberUS157852
Device Lot Number473320
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/24/2020
Initial Date FDA Received05/18/2020
Supplement Dates Manufacturer Received07/06/2020
Supplement Dates FDA Received07/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Treatment
SEE H10 NARRATIVE
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age48 YR
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