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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET ORTHOPEDICS BIOMET BIPOLAR PROSTHESIS PROSTHESIS, HIP

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BIOMET ORTHOPEDICS BIOMET BIPOLAR PROSTHESIS PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problems Mechanical Problem (1384); Unstable (1667); Noise, Audible (3273)
Patient Problems Pain (1994); Reaction (2414)
Event Date 06/17/2015
Event Type  Injury  
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information. Visual examination of the returned product identified: a m2a-magnum mod hd sz 46mm, part # 157446 from lot 545290, was returned and evaluated against the complaint. Visual inspection found the head to scuffed and worn consistent with metal on metal construction. Tool marks were observed around the rim corresponding to the location of tool marks observed on the adapter. A m2a-magnum 42-50mm tpr insrt-3, part # 139254 from lot 708220, was returned and evaluated against the complaint. Visual inspection found scratching on the exposed face of the adapter. Tool marks were observed around the rim corresponding to the location of tool marks observed on the rim of the head. Visual examination of the conical taper of the m2a magnum taper adapter (lot 708220) shows damage in the form of dark debris and burnishing / scuffing. Reference photos. Additional information does not change the root cause of the previous investigation. 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.
 
Event Description
No further event information available at the time of this report.
 
Manufacturer Narrative
(b)(4). Concomitant medical products ¿ biomet m2a magnum cup, catalog#: us157852, lot#: 454850. Biomet bi-metric stem, catalog #: x180312, lot#: 767540. There are warnings in the package insert that these types of events can occur. Under possible adverse effects, number 1 states, "material sensitivity reactions. Implantation of foreign material in tissues may result in histological reactions involving various sizes of macrophages and fibroblasts. " and, "particulate wear debris and discoloration from metallic and polyethylene components of joint implants may be present in adjacent tissue or fluid. " number 10 states, "fretting and crevice corrosion may occur at interfaces between components. " number 14 states, "intraoperative or postoperative bone fracture and/or postoperative pain. " number 15 states, "elevated metal ion levels have been reported with metal on metal articulating surfaces. " current information is insufficient to permit a conclusion as to the cause of the event. Review of device history records found no evidence of product nonconformance. 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.
 
Event Description
Legal counsel for patient reported the patient underwent a right hip revision nine years post-implantation due to metal-on-metal complications. This report is based on allegations set forth in plaintiff¿s complaint and the allegations contained therein are unverified. Medical records indicate the patient was revised due to pain, instability and clicking from the joint, elevated metal ion levels and unspecified mechanical symptoms. Revision operative report notes metallosis, grey-staining and metallic-staining of the capsule, staining of the proximal femur trunnion, and proximal femur osteolysis. The femoral head and taper adapter were removed and replaced and a dual mobility bearing was implanted.
 
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Brand NameBIOMET BIPOLAR PROSTHESIS
Type of DevicePROSTHESIS, HIP
Manufacturer (Section D)
BIOMET ORTHOPEDICS
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
BIOMET ORTHOPEDICS
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key6407252
MDR Text Key110615394
Report Number0001825034-2017-01577
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK833175
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/15/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2016
Device Model NumberN/A
Device Catalogue Number157446
Device Lot Number545290
Other Device ID NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/12/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/18/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/05/2006
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 03/15/2017 Patient Sequence Number: 1
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