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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET ORTHOPEDICS M2A ACETABULAR SYSTEM PROSTHESIS, HIP

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BIOMET ORTHOPEDICS M2A ACETABULAR SYSTEM PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Metal Shedding Debris (1804)
Patient Problems Wound Dehiscence (1154); Pain (1994); Tissue Damage (2104); Discomfort (2330)
Event Date 12/02/2014
Event Type  Injury  
Manufacturer Narrative
(b)(4). The following report is submitted to relay additional and corrected information. Concomitant medical products: part#: rd118858 lot#: 591260; m2a 38 mm x 58 mm cup, part#: 11-103207 lot#: 477490; taperloc lat pc 13. 5 mm t1. The reported event is confirmed. No product was returned; the visual and dimensional evaluations could not be performed. Device history record (dhr) review identified no discrepancies. Review of the primary op notes dated (b)(6) 2004 indicates that the patient underwent an initial right tha procedure due to degenerative joint diseases for the right hip. During the procedure surgeon noted patient had severe articular cartilage disease with subchondral sclerosis in the femoral head and eburnated acetabulum. Surgeon also noted patient had large cavity bone defect. Revision operative findings show surgeon noted massive amount of a brown gray material within the joint itself which is very poor quality tissue, also dark brown/gray fluid through the tissue and bone loss surrounding about 50% of the acetabulum implant. Surgeon also noted patient had large cavity bone defect. Surgeon performed bone grafting behind the cup. A definitive root cause for the reported event could not be determined with information available. No corrective actions, preventive actions, or field actions resulted after investigation of this event. 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.
 
Manufacturer Narrative
The complaint number corresponding to this medwatch is (b)(4). 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. Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2017 - 02480.
 
Event Description
It was reported by patients legal counsel that the patient was revised approximately ten years post-implantation due to metallic stained tissue, dehiscence of the posterior hip implant capsule, and elevated levels of cobalt and chromium. Medical records noted brown gray material within the joint and throughout the tissue, bone loss around the acetabulum, muscles around the joint were damaged and loose. It was also noted that the patient had large cavity bone defect. Debridement was performed.
 
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Brand NameM2A ACETABULAR SYSTEM
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 Key6790002
MDR Text Key110655857
Report Number0001825034-2017-02479
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK011110
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/18/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/11/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2014
Device Model NumberN/A
Device Catalogue NumberRD118858
Device Lot Number591260
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/18/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/08/2004
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 08/11/2017 Patient Sequence Number: 1
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